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RecallWatchMedical Device Safety
Class IIOngoingZ-0892-2025

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Discovery NM/CT 670 DR

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGTirat Carmel, IsraelReported Jan 22, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

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 Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission

Lot / code information

Serial #
NT2JG1800001; UDI/DI N/A, System IDNT4014
Serial #
T2HG1700003/ 158624HL7; UDI/DI N/A, System IDNT4017
Serial #
157120HL7; UDI/DI N/A, System IDNT7001
Serial #
156620HL7; UDI/DI N/A, System IDNT7005
Serial #
159731HL9. 2) H2401AW: UDI/DI 840682140898, System ID N/A
Serial #
NT2JG1800004; UDI/DI 840682140898, System ID N/A
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NT2JG1800005; UDI/DI 840682140898, System ID N/A
Serial #
NT2JG1800006; UDI/DI 840682140898, System ID N/A
Serial #
NT2JG1800007; UDI/DI 840682140898, System ID N/A
Serial #
NT2JG1800008; UDI/DI 840682140898, System ID N/A
Show 66 more code fields
Serial #
NT2JG1800009; UDI/DI 840682140898, System ID LY1198CT02
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NT2JG1800010; UDI/DI N/A, System ID N/A
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T2HG1700001; UDI/DI N/A, System ID N/A
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T2HG1700002; UDI/DI N/A, System ID N/A
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T2HG1800004; UDI/DI N/A, System ID N/A
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T2HG1800001; UDI/DI N/A, System ID N/A
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T2HG1800002; UDI/DI N/A, System ID N/A
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T2HG1800003; UDI/DI N/A, System ID N/A
Serial #
T2JG1800001. 3) H3100AN: UDI/DI 840682124393, System ID 501257D670
Serial #
DDRX34049; UDI/DI 840682124393, System ID 909558D670NM
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DDRX34058; UDI/DI 840682124393, System ID 215707D670
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DDRW34002; UDI/DI 840682124393, System ID Not Available
Serial #
DDRW34004; UDI/DI 840682124393, System ID 786257NMD670
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DDRW34005; UDI/DI 840682124393, System ID 773702NM670
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DDRW34006; UDI/DI 840682124393, System ID ZWL0680
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DDRW34007; UDI/DI 840682124393, System ID FI1019MN02
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DDRW34008; UDI/DI 840682124393, System ID 0850260162
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DDRW34009; UDI/DI 840682124393, System ID 450359D670
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DDRW34010; UDI/DI 840682124393, System ID FI1064NU02
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DDRW34011; UDI/DI 840682124393, System ID M40180135
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DDRW34012; UDI/DI 840682124393, System ID 541CMINM
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DDRW34013; UDI/DI 840682124393, System ID 030029NU08
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DDRW34014; UDI/DI 840682124393, System ID 832826NM
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DDRW34015; UDI/DI 840682124393, System ID 772332NU01
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DDRW34016; UDI/DI 840682124393, System ID 814269D670NM
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DDRW34017; UDI/DI 840682124393, System ID 519752D670
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DDRW34018; UDI/DI 840682124393, System ID E001NU21
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DDRW34019; UDI/DI 840682124393, System ID ENS0132
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DDRW34020; UDI/DI 840682124393, System ID FI1021MN03
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DDRW34021; UDI/DI 840682124393, System ID 708216NM670
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DDRW34023; UDI/DI 840682124393, System ID 450771D670
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DDRW34024; UDI/DI 840682124393, System ID 00361NUC11
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DDRW34025; UDI/DI 840682124393, System ID MPX57807
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DDRW34026; UDI/DI 840682124393, System ID CC0618NU15
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DDRW34027; UDI/DI 840682124393, System ID 83167403240
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DDRW34028; UDI/DI 840682124393, System ID B1768016
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DDRW34030; UDI/DI 840682124393, System ID Not Available
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DDRW34031; UDI/DI 840682124393, System ID 513584NM670
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DDRW34032; UDI/DI 840682124393, System ID 00432NUC07
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DDRW34033; UDI/DI 840682124393, System ID 00440NUC32
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DDRW34034; UDI/DI 840682124393, System ID A173433206
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DDRW34035; UDI/DI 840682124393, System ID Not Available
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DDRX34036; UDI/DI 840682124393, System ID 6073MI0009
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DDRX34037; UDI/DI 840682124393, System ID V1471127
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DDRX34039; UDI/DI 840682124393, System ID 414805DISC
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DDRX34041; UDI/DI 840682124393, System ID 450468D670
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DDRX34042; UDI/DI 840682124393, System ID 06184NUC07
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DDRX34043; UDI/DI 840682124393, System ID M4480271
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DDRX34044; UDI/DI 840682124393, System ID 414328DISC
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DDRX34045; UDI/DI 840682124393, System ID 415300D670
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DDRX34046; UDI/DI 840682124393, System ID M4038073
Serial #
DDRX34047; UDI/DI 840682124393, System ID 11018NUC14
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DDRX34051; UDI/DI 840682124393, System ID 083026282101818
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DDRX34052; UDI/DI 840682124393, System ID 0853260197
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DDRX34054; UDI/DI 840682124393, System ID 00362NUC04
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DDRX34055; UDI/DI N/A, System ID 650723D670
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DDRX34056; UDI/DI N/A, System ID 801545XEL1
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DDRX34038; UDI/DI N/A, System ID 802847SPEC670
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DDRW34003; UDI/DI N/A, System ID NMDDRX34053
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DDRX34053; UDI/DI N/A, System ID M4234247
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DDRW34001; UDI/DI N/A, System ID NT7002
Serial #
T2BG1700046/ DDRW34029; UDI/DI N/A, System ID NT7002
Serial #
DDRW34029. 4) H3100BT: UDI/DI 840682139359, System ID1000000606
Serial #
DRGX56002; UDI/DI 840682139359, System ID09953506
Serial #
DRGX56012. 5) H3100PX: UDI/DI 00840682124393, System ID 83169440013
Serial #
DDRW34022

What the firm is doing

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/18/2024. The notice explained the safety issue and requested the following actions be taken: There are two populations potentially affected by this notification: NOTE: Specific serial numbers of the following affected systems: Infinia Nuclear Medicine Systems: Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4; VG Nuclear Medicine systems: Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH; Brivo NM 615; Discovery NM 630; Discovery NM/CT 670, Discovery NM/CT 670 ES, Discovery NM/CT 670 DR, Discovery NM/CT 670 PRO, Discovery NM/CT 670 CZT; Optima NM/CT 640. For Serial Numbers listed in Appendix A of this letter: GE HealthCare requests that you STOP USING the system until GE HealthCare has inspected and if necessary, corrected your system and provided you with a letter indicating the system can be returned to clinical use. GE HealthCare has determined that these systems could have previously been transported or relocated without proper detector support. For Serial Numbers listed in Appendix B of this letter: You can continue to use your system, as GE HealthCare has determined that these systems have not previously been transported or relocated without proper detector support. For Serial Numbers listed in either Appendix A or Appendix B of this letter: GE HealthCare requests that you DO NOT physically relocate or transport your system from its current location. If you need to move or transport your system, please email GE HealthCare at recall.40910@gehealthcare.com to receive specific instructions to follow before moving the system. When emailing this address, please provide the following information: " System serial number " Current system location " The reason for the move or transport, and subsequent destination Do not proceed with a physical relocation or transport of your system until you have received these instructions and taken the actions descri

DistributionShow details

Worldwide

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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