GE Medical Systems recalls OEC Elite and OEC 3D Mobile C-Arms that may exceed 4% source-to-image distance in X-ray field, potentially affecting safety during medical procedures. Systems with specific serial numbers listed in Appendix A are affected.
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
GE Medical Systems is recalling certain OEC Elite and OEC 3D Mobile C-Arms that may have an X-ray field size larger than the 4% source-to-image distance limit. This could affect the safety of medical procedures if the device is used without proper adjustments. Affected units have specific serial numbers listed in Appendix A.
The X-ray field size may exceed the 4% source-to-image distance limit, which could lead to improper imaging during medical procedures. However, the recall does not indicate a risk of serious injury or death in normal use, as the issue relates to measurement accuracy rather than immediate safety hazards.
Healthcare providers using the OEC Elite Mobile C-arm systems or OEC 3D Mobile C-arm systems with specific serial numbers listed in Appendix A are most at risk. Systems not listed in Appendix A may also be affected but lack the acceptance limit for X-ray field size measurement in the System Service Manual.
Check if your OEC Elite Mobile C-arm or OEC 3D Mobile C-arm has a serial number listed in Appendix A (e.g., FAHXTX00002, FAHXTX00005, etc.). The recall applies to systems with specific GTINs: 00001234567895 and 00195278096944.
Review the serial numbers listed in Appendix A to determine if your device is affected.
Reach out to GE Medical Systems for further guidance on whether your device requires correction or adjustment.
The recall specifies that the X-ray field size should not exceed 4% source-to-image distance. Devices with a field size larger than this limit are affected.
No. Only devices with specific serial numbers listed in Appendix A (e.g., FAHXTX00002, FAHXTX00005) are affected. Systems not listed in Appendix A may also be affected but lack the acceptance limit for X-ray field size measurement in the System Service Manual.
Check if your device's serial number is listed in Appendix A. The recall includes specific serial numbers like FAHXTX00002, FAHXTX00005, and others.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1819-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-1819-2025 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
