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RecallWatchMedical Device Safety
Class IIOngoingZ-2030-2025

GE Medical Systems China Co., Ltd. recalls GE Healthcare Versana Ultrasound Systems

GE Medical Systems China Co., Ltd.Wuxi, ChinaReported Jul 2, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system

Lot / code information

Catalog #
5938558, UDI/DI (01)00195278690388(11)241127(21)6302036WX0, Lot/
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6302036WX0; Model/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302045WX0, Lot/
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6302045WX0; Model/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302035WX0, Lot/
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6302035WX0; Model/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302046WX0, Lot/
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6302046WX0; Model/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302033WX0, Lot/
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6302033WX0; Model/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302034WX0, Lot/
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6302034WX0; Model/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302041WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302040WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302039WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302044WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302043WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302038WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302037WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302047WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241127(21)6302042WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241125(21)6302029WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250214(21)6302080WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250214(21)6302078WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250214(21)6302079WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250214(21)6302077WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250108(21)6302073WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250107(21)6302070WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250107(21)6302072WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250310(21)6302087WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250228(21)6302083WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250117(21)6302075WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)241031(21)6302027WX0, Lot/
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5938558, UDI/DI (01)00195278690388(11)250205(21)6302076WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241107(21)6304133WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241126(21)6304157WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241206(21)6304193WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241202(21)6304163WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241230(21)6304218WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241107(21)6304132WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)240929(21)6304073WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)240927(21)6304071WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241218(21)6304214WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241230(21)6304219WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241206(21)6304183WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241202(21)6304162WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241202(21)6304164WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)240929(21)6304072WX0, Lot/
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6304072WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241022(21)6304089WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241022(21)6304091WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241022(21)6304094WX0, Lot/
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6304094WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241022(21)6304101WX0, Lot/
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6304101WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)240821(21)6304029WX0, Lot/
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6304029WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241106(21)6304124WX0, Lot/
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6304124WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250208(21)6304282WX0, Lot/
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6304282WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241022(21)6304097WX0, Lot/
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6304097WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241209(21)6304211WX0, Lot/
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6304211WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241024(21)6304109WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241126(21)6304154WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241018(21)6304086WX0, Lot/
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6304086WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241127(21)6304158WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241127(21)6304159WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241126(21)6304156WX0, Lot/
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6304156WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241024(21)6304021WX0, Lot/
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6304021WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241126(21)6304155WX0, Lot/
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6304155WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241024(21)6304110WX0, Lot/
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6304110WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241024(21)6304107WX0, Lot/
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6304107WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250219(21)6304333WX0, Lot/
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6304333WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250224(21)6304368WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250221(21)6304367WX0, Lot/
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6304367WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250224(21)6304369WX0, Lot/
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6304369WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250115(21)6304255WX0, Lot/
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6304255WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250115(21)6304263WX0, Lot/
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6304263WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250115(21)6304270WX0, Lot/
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6304270WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250115(21)6304269WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250115(21)6304258WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250115(21)6304262WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250115(21)6304259WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)240822(21)6304056WX0, Lot/
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6304056WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250213(21)6304311WX0, Lot/
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6304311WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250212(21)6304309WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250313(21)6304399WX0, Lot/
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6304399WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)240822(21)6304047WX0, Lot/
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6304047WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241015(21)6304079WX0, Lot/
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6304079WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241015(21)6304078WX0, Lot/
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6304078WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241108(21)6304139WX0, Lot/
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6304139WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241209(21)6304208WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250103(21)6304226WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250220(21)6304346WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250220(21)6304345WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)240821(21)6304035WX0, Lot/
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6304035WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241204(21)6304167WX0, Lot/
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6304167WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241108(21)6304138WX0, Lot/
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6304138WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241029(21)6304112WX0, Lot/
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6304112WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241029(21)6304113WX0, Lot/
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6304113WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250214(21)6304314WX0, Lot/
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6304314WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250214(21)6304315WX0, Lot/
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6304315WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250214(21)6304316WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250214(21)6304317WX0, Lot/
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6304317WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250214(21)6304318WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250314(21)6304415WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250314(21)6304416WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)250314(21)6304417WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241030(21)6304111WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241209(21)6304202WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241206(21)6304200WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241204(21)6304172WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241204(21)6304166WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241204(21)6304182WX0, Lot/
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5938559, UDI/DI (01)00195278690395(11)241204(21)6304175WX0, Lot/
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6304175WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)241204(21)6304178WX0, Lot/
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6304178WX0; Model/
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5938559, UDI/DI (01)00195278690395(11)250221(21)6304355WX0, Lot/
Serial #
6304355WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304038WX0, Lot/
Serial #
6304038WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241204(21)6304177WX0, Lot/
Serial #
6304177WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304280WX0, Lot/
Serial #
6304280WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241111(21)6304141WX0, Lot/
Serial #
6304141WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241030(21)6304115WX0, Lot/
Serial #
6304115WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304044WX0, Lot/
Serial #
6304044WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241209(21)6304209WX0, Lot/
Serial #
6304209WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241209(21)6304212WX0, Lot/
Serial #
6304212WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304278WX0, Lot/
Serial #
6304278WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304357WX0, Lot/
Serial #
6304357WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304040WX0, Lot/
Serial #
6304040WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304028WX0, Lot/
Serial #
6304028WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241112(21)6304144WX0, Lot/
Serial #
6304144WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241204(21)6304181WX0, Lot/
Serial #
6304181WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304058WX0, Lot/
Serial #
6304058WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241030(21)6304114WX0, Lot/
Serial #
6304114WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241101(21)6304118WX0, Lot/
Serial #
6304118WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241106(21)6304121WX0, Lot/
Serial #
6304121WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241108(21)6304136WX0, Lot/
Serial #
6304136WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250106(21)6304233WX0, Lot/
Serial #
6304233WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304352WX0, Lot/
Serial #
6304352WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304027WX0, Lot/
Serial #
6304027WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304046WX0, Lot/
Serial #
6304046WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241209(21)6304207WX0, Lot/
Serial #
6304207WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304042WX0, Lot/
Serial #
6304042WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241204(21)6304176WX0, Lot/
Serial #
6304176WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304288WX0, Lot/
Serial #
6304288WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304030WX0, Lot/
Serial #
6304030WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240823(21)6304064WX0, Lot/
Serial #
6304064WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241022(21)6304092WX0, Lot/
Serial #
6304092WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241022(21)6304093WX0, Lot/
Serial #
6304093WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250212(21)6304307WX0, Lot/
Serial #
6304307WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250212(21)6304301WX0, Lot/
Serial #
6304301WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250212(21)6304304WX0, Lot/
Serial #
6304304WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240820(21)6304024WX0, Lot/
Serial #
6304024WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304054WX0, Lot/
Serial #
6304054WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304201WX0, Lot/
Serial #
6304201WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241209(21)6304204WX0, Lot/
Serial #
6304204WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250103(21)6304227WX0, Lot/
Serial #
6304227WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304295WX0, Lot/
Serial #
6304295WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250212(21)6304305WX0, Lot/
Serial #
6304305WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250212(21)6304302WX0, Lot/
Serial #
6304302WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304049WX0, Lot/
Serial #
6304049WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304061WX0, Lot/
Serial #
6304061WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304060WX0, Lot/
Serial #
6304060WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241015(21)6304081WX0, Lot/
Serial #
6304081WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241015(21)6304082WX0, Lot/
Serial #
6304082WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241204(21)6304180WX0, Lot/
Serial #
6304180WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241204(21)6304179WX0, Lot/
Serial #
6304179WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304199WX0, Lot/
Serial #
6304199WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304198WX0, Lot/
Serial #
6304198WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250212(21)6304306WX0, Lot/
Serial #
6304306WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241022(21)6304096WX0, Lot/
Serial #
6304096WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241022(21)6304095WX0, Lot/
Serial #
6304095WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241209(21)6304206WX0, Lot/
Serial #
6304206WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304195WX0, Lot/
Serial #
6304195WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250106(21)6304236WX0, Lot/
Serial #
6304236WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241022(21)6304090WX0, Lot/
Serial #
6304090WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304039WX0, Lot/
Serial #
6304039WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304041WX0, Lot/
Serial #
6304041WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304048WX0, Lot/
Serial #
6304048WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304052WX0, Lot/
Serial #
6304052WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304050WX0, Lot/
Serial #
6304050WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304291WX0, Lot/
Serial #
6304291WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304293WX0, Lot/
Serial #
6304293WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241112(21)6304149WX0, Lot/
Serial #
6304149WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241112(21)6304142WX0, Lot/
Serial #
6304142WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241024(21)6304108WX0, Lot/
Serial #
6304108WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304246WX0, Lot/
Serial #
6304246WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250211(21)6304299WX0, Lot/
Serial #
6304299WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250115(21)6304261WX0, Lot/
Serial #
6304261WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241108(21)6304137WX0, Lot/
Serial #
6304137WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304356WX0, Lot/
Serial #
6304356WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250220(21)6304348WX0, Lot/
Serial #
6304348WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250106(21)6304235WX0, Lot/
Serial #
6304235WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250219(21)6304337WX0, Lot/
Serial #
6304337WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304192WX0, Lot/
Serial #
6304192WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241204(21)6304171WX0, Lot/
Serial #
6304171WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241204(21)6304174WX0, Lot/
Serial #
6304174WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250213(21)6304310WX0, Lot/
Serial #
6304310WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250212(21)6304308WX0, Lot/
Serial #
6304308WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304281WX0, Lot/
Serial #
6304281WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241204(21)6304173WX0, Lot/
Serial #
6304173WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241031(21)6304117WX0, Lot/
Serial #
6304117WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241112(21)6304147WX0, Lot/
Serial #
6304147WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304032WX0, Lot/
Serial #
6304032WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304364WX0, Lot/
Serial #
6304364WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250220(21)6304341WX0, Lot/
Serial #
6304341WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250219(21)6304334WX0, Lot/
Serial #
6304334WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241015(21)6304084WX0, Lot/
Serial #
6304084WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240821(21)6304033WX0, Lot/
Serial #
6304033WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304359WX0, Lot/
Serial #
6304359WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304290WX0, Lot/
Serial #
6304290WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241112(21)6304150WX0, Lot/
Serial #
6304150WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250220(21)6304343WX0, Lot/
Serial #
6304343WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304354WX0, Lot/
Serial #
6304354WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304189WX0, Lot/
Serial #
6304189WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241106(21)6304126WX0, Lot/
Serial #
6304126WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304296WX0, Lot/
Serial #
6304296WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304191WX0, Lot/
Serial #
6304191WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241106(21)6304127WX0, Lot/
Serial #
6304127WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241129(21)6304161WX0, Lot/
Serial #
6304161WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250120(21)6304275WX0, Lot/
Serial #
6304275WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250120(21)6304273WX0, Lot/
Serial #
6304273WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250220(21)6304350WX0, Lot/
Serial #
6304350WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241022(21)6304098WX0, Lot/
Serial #
6304098WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304279WX0, Lot/
Serial #
6304279WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304247WX0, Lot/
Serial #
6304247WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304248WX0, Lot/
Serial #
6304248WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304249WX0, Lot/
Serial #
6304249WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304250WX0, Lot/
Serial #
6304250WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304251WX0, Lot/
Serial #
6304251WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304252WX0, Lot/
Serial #
6304252WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304253WX0, Lot/
Serial #
6304253WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250114(21)6304254WX0, Lot/
Serial #
6304254WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241107(21)6304135WX0, Lot/
Serial #
6304135WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241107(21)6304134WX0, Lot/
Serial #
6304134WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304297WX0, Lot/
Serial #
6304297WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304324WX0, Lot/
Serial #
6304324WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304325WX0, Lot/
Serial #
6304325WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304329WX0, Lot/
Serial #
6304329WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304328WX0, Lot/
Serial #
6304328WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304326WX0, Lot/
Serial #
6304326WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304327WX0, Lot/
Serial #
6304327WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304330WX0, Lot/
Serial #
6304330WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304331WX0, Lot/
Serial #
6304331WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304322WX0, Lot/
Serial #
6304322WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304323WX0, Lot/
Serial #
6304323WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304321WX0, Lot/
Serial #
6304321WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304319WX0, Lot/
Serial #
6304319WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304320WX0, Lot/
Serial #
6304320WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250217(21)6304332WX0, Lot/
Serial #
6304332WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304197WX0, Lot/
Serial #
6304197WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241206(21)6304194WX0, Lot/
Serial #
6304194WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304360WX0, Lot/
Serial #
6304360WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250106(21)6304230WX0, Lot/
Serial #
6304230WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304059WX0, Lot/
Serial #
6304059WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304292WX0, Lot/
Serial #
6304292WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304287WX0, Lot/
Serial #
6304287WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304289WX0, Lot/
Serial #
6304289WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250220(21)6304344WX0, Lot/
Serial #
6304344WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250220(21)6304349WX0, Lot/
Serial #
6304349WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304365WX0, Lot/
Serial #
6304365WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304057WX0, Lot/
Serial #
6304057WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304055WX0, Lot/
Serial #
6304055WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304283WX0, Lot/
Serial #
6304283WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250208(21)6304285WX0, Lot/
Serial #
6304285WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250212(21)6304303WX0, Lot/
Serial #
6304303WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250219(21)6304335WX0, Lot/
Serial #
6304335WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250220(21)6304342WX0, Lot/
Serial #
6304342WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250220(21)6304347WX0, Lot/
Serial #
6304347WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250221(21)6304363WX0, Lot/
Serial #
6304363WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250224(21)6304370WX0, Lot/
Serial #
6304370WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)240822(21)6304053WX0, Lot/
Serial #
6304053WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)241022(21)6304088WX0, Lot/
Serial #
6304088WX0; Model/
Catalog #
5938559, UDI/DI (01)00195278690395(11)250219(21)6304338WX0, Lot/
Serial #
6304338WX0; Model/Ca
Additional code information

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Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240929(21)6360515WX0, Lot/Serial Number 6360515WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240929(21)6360518WX0, Lot/Serial Number 6360518WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240927(21)6360512WX0, Lot/Serial Number 6360512WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)241105(21)6360524WX0, Lot/Serial Number 6360524WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)241105(21)6360528WX0, Lot/Serial Number 6360528WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)241105(21)6360525WX0, Lot/Serial Number 6360525WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)241008(21)6360519WX0, Lot/Serial Number 6360519WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)241008(21)6360521WX0, Lot/Serial Number 6360521WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)241105(21)6360527WX0, Lot/Serial Number 6360527WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)241105(21)6360526WX0, Lot/Serial Number 6360526WX0; 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Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240821(21)6360502WX0, Lot/Serial Number 6360502WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240821(21)6360503WX0, Lot/Serial Number 6360503WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240822(21)6360507WX0, Lot/Serial Number 6360507WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240821(21)6360501WX0, Lot/Serial Number 6360501WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240822(21)6360511WX0, Lot/Serial Number 6360511WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240929(21)6360514WX0, Lot/Serial Number 6360514WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240929(21)6360516WX0, Lot/Serial Number 6360516WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)240822(21)6360508WX0, Lot/Serial Number 6360508WX0; Model/Catalog Number 5946387, UDI/DI (01)00195278752550(11)250120(21)6360563WX0, Lot/Serial Number 6360563WX0; Model/Catalog Number 5946481, UDI/DI (01)00195278752567(11)241126(21)6361005WX0, Lot/Serial Number 6361005WX0; 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What the firm is doing

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 05/16/2025 via letter delivered using a traceable means. The notice explained the issue, potential risk, and requested the following: "Actions to be taken by Customer/User: You may continue to use your Versana Premier R3 and LOGIQ F R3 series ultrasound systems by following the actions below: 1) If you use the Whizz report feature, reboot the system after finishing each obstetric patient examination. OR 2) Instead of using the Whizz report feature, after completing an obstetric patient examination, print all obstetric measurement and calculation results from the worksheet directly. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.71082@gehealthcare.com." If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

DistributionShow details

Worldwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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