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RecallWatchMedical Device Safety
Class IIOngoingZ-1819-2025

GE Medical Systems, LLC recalls OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital s…

GE Medical Systems, LLCWaukesha, WI, United StatesReported Jun 18, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

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.

Affected products & lots

  • OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures
    GTIN 00001234567895
    400 affected lots
    FAHXTX00002FAHXTX00005FAHXTX00014FAHXTX00018FAHXTX00019FAHXTX00020FAHXTX00024FAHXTX00028
    +392 moreFAHXTX00034FAHXTX00037FAHXTX00043FAHXTX00052FAHXTX00063FAHXTX00066FAHXTX00068FAHXTX00070FAHXTX00075FAHXTX00078FAHXTX00079FAHXTX00080FAHXTX00081FAHXTX00083FAHXTX00092FAHXTX00093FAHXTX00097FAHXTX00110FAHXTX00111FAHXTX00112FAHXTX00114FAHXTX00115FAHXTX00116FAHXTX00117FAHXTX00118FAHXTX00119FAHXTX00120FAHXTX00121FAHXTX00122FAHXTX00124FAHXTX00125FAHXTX00135FAHXTX00137FAHXTX00138FAHXTX00151FAHXTX00152FAHXTX00155FAHXTX00156FAHXTX00162FAHXTX00163FAHXTX00166FAHXTX00170FAHXTX00171FAHXTX00177FAHXTX00178FAHXTX00188FAHXTX00192FAHXTX00193FAHXTX00202FAHXTX00204FAHXTX00211FAHXTX00212FAHXTX00217FAHXTX00219FAHXTX00220FAHXTX00221FAHXTX00222FAHXTX00223FAHXTX00224FAHXTX00226FAHXTX00227FAHXTX00229FAHXTX00230FAHXTX00236FAHXTX00240FAHXTX00244FAHXTX00261FAHXTX00265FAHXTX00266FAHXTX00269FAHXTX00271FAHXTX00272FAHXTX00273FAHXTX00274FAHXTX00280FAHXTX00283FAHXTX00284FAHXTX00296FAHXTX00299FAHXTX00300FAHXTX00304FAHXTX00305FAHXTX00308FAHXTX00312FAHXTX00313FAHXTX00320FAHXTX00323FAHXTX00325FAHXTX00332FAHXTX00340FAHXTX00342FAHXTX00343FAHXTX00352FAHXTX00353FAHXTX00354FAHXTX00357FAHXTX00358FAHXTX00359FAHXTX00360FAHXTX00363FAHXTX00376FAHXTX00379FAHXTX00381FAHXTX00382FAHXTX00390FAHXTX00392FAHXTX00399FAHXTX00400FAHXTX00410FAHXTX00413FAHXTX00414FAHXTX00415FAHXTX00420FAHXTX00421FAHXTX00429FAHXTX00439FAHXTX00453FAHXTX00455FAHXTX00456FAHXTX00463FAHXTX00465FAHXTX00466FAHXTX00479FAHXTX00481FAHXTX00483FAHXTX00484FAHXTX00486FAHXTX00488FAHXTX00495FAHXTX00497FAHXTX00498FAHXTX00507FAHXTX00509FAHXTX00513FAHXTX00523FAHXTX00530FAHXTX00534FAHXTX00538FAHXTX00539FAHXTX00540FAHXTX00547FAHXTX00549FAHXTX00555FAHXTX00557FAHXTX00560FAHXTX00565FAHXTX00569FAHXTX00570FAHXTX00571FAHXTX00572FAHXTX00575FAHXTX00576FAHXTX00579FAHXTX00592FAHXTX00595FAHXTX00610FAHXTX00611FAHXXX00029FAHXXX00030FAHXXX00038FAHXXX00040FAHXXX00056FAHXXX00057FAHXXX00059FAHXXX00060FAHXXX00061FAHXXX00069FAHXXX00082FAHXXX00085FAHXXX00086FAHXXX00089FAHXXX00091FAHXXX00093FAHXXX00097FAHXXX00098FAHXXX00099FAHXXX00105FAHXXX00106FAHXXX00112FAHXXX00113FAHXXX00114FAHXXX00116FAHXXX00117FAHXXX00119FAHXXX00123FAHXXX00142FAHXXX00144FAHXXX00145FAHXXX00147FAHXXX00150FAHXXX00151FAHXXX00153FAHXXX00155FAHXXX00164FAHXXX00173FAHXXX00176FAHXXX00178FAHXXX00179FAHXXX00188FAHXXX00190FAHXXX00193FAHXXX00196FAHXXX00199FAHXXX00200FAHXXX00207FAHXXX00208FAHXXX00209FAMHTX00001FAMHTX00005FAMHTX00007FAMHTX00012FAMHTX00014FAMHTX00041FAMHTX00051FAMHTX00055FAMHTX00064FAMHTX00069FAMHTX00081FAMHTX00085FAMHXX00003FAMHXX00011FAMHXX00019FAMHXX00023FAXXTE00003FAXXTE00006FAXXTE00009FAXXTE00011FAXXTE00013FAXXTE00014FAXXTE00015FAXXTE00017FAXXTE00021FAXXTE00022FAXXTE00024FAXXTE00025FAXXTE00028FAXXTE00031FAXXTE00032FAXXTE00033FAXXTE00034FAXXTE00035FAXXTE00037FAXXTE00038FAXXTE00039FAXXTE00040FAXXTE00044FAXXTE00046FAXXTE00047FAXXTE00049FAXXTE00050FAXXTE00051FAXXTE00052FAXXTE00056FAXXTE00062FAXXTE00063FAXXTE00064FAXXTE00067FAXXTE00071FAXXTE00072FAXXTE00073FAXXTE00076FAXXTE00084FAXXTE00085FAXXTE00091FAXXTE00092FAXXTE00094FAXXTE00095FAXXTE00099FAXXTE00100FAXXTE00101FAXXTE00104FAXXTE00105FAXXTE00106FAXXTE00107FAXXTE00109FAXXTE00110FAXXTE00114FAXXTE00116FAXXTE00117FAXXTE00120FAXXTE00121FAXXTE00128FAXXTE00129FAXXTE00134FAXXTE00136FAXXTE00137FAXXTE00141FAXXTE00144FAXXTE00145FAXXTE00147FAXXTE00149FAXXTE00163FAXXTE00164FAXXTE00170FAXXTE00173FAXXTE00175FAXXTE00179FAXXTE00180FAXXTE00182FAXXTE00184FAXXTE00185FAXXTE00195FAXXTE00197FAXXTE00205FAXXTE00212FAXXTE00220FAXXTE00224FAXXTE00225FAXXTE00227FAXXTE00228FAXXTE00229FAXXTE00230FAXXTE00231FAXXTE00234FAXXTE00236FAXXTE00237FAXXTE00238FAXXTE00240FAXXTE00241FAXXTE00243FAXXTE00246FAXXTE00248FAXXTE00253FAXXTE00256FAXXTE00257FAXXTE00258FAXXTE00259FAXXTE00263FAXXTE00267FAXXTE00269FAXXTE00270FAXXTE00271FAXXTE00272FAXXTE00277FAXXTE00278FAXXTE00279FAXXTE00280FAXXTE00282FAXXTE00286FAXXTE00291FAXXTE00293FAXXTE00295FAXXTE00301FAXXTE00317FAXXTE00319FAXXTE00320FAXXTE00321FAXXTE00323FAXXTE00328FAXXTE00329FAXXTE00330FAXXTE00331FAXXTE00334FAXXTE00336FAXXTE00337FAXXTE00338FAXXTE00339FAXXTE00340FAXXTE00342FAXXTE00344FAXXTE00352FAXXTE00353FAXXTE00354FAXXTE00357FAXXTE00358FAXXTE00361FAXXTE00362FAXXTE00363FAXXTE00372FAXXTE00373FAXXTE00376FAXXTE00379FAXXTE00380FAXXTE00383FAXXTE00389FAXXTE00392FAXXTE00393FAXXTE00396FAXXTE00407FAXXTE00413FAXXTE00418FAXXTE00422FAXXTE00424FAXXTE00425FAXXTE00429FAXXTE00431FAXXTE00433FAXXTE00434FAXXTE00436FAXXTE00439FAXXTE00442FAXXTE00443

What the firm is doing

All impacted customers with receive a customer letter notifying them of the potential issue. GE HealthCare will send a field service engineer to perform measurements of the Xray field on the identified systems (listed in Appendix A of the customer letter).

DistributionShow details

US and OUS

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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