GE Healthcare recalls OEC 9900 C-Arm fluoroscopy systems in the US that may not display required dose values per regulations. Affected units were configured to show AKR/CAK instead of DAP when leaving the factory.
GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.
GE Healthcare is recalling some OEC 9900 C-Arm fluoroscopy systems sold in the US because they were configured to display AKR/CAK dose values instead of the required DAP values. This configuration does not comply with federal regulations that mandate specific dose display for fluoroscopic equipment manufactured after June 2006.
The system was configured to display AKR/CAK dose values instead of the required DAP values when leaving the factory. This configuration does not comply with federal regulations that mandate specific dose display for fluoroscopic equipment manufactured after June 10, 2006. The issue does not pose an immediate safety risk but requires regulatory compliance.
Medical professionals using the OEC 9900 C-Arm fluoroscopy systems in the US. Patients receiving procedures with these systems may be at low risk if the dose display issue is corrected.
Check if your OEC 9900 C-Arm fluoroscopy system was sold in the US and displays AKR/CAK on the live update screen instead of DAP. Systems that left GE Healthcare (the place of manufacture) are configured to show AKR/CAK by default.
Verify if your system shows AKR/CAK instead of DAP on the live update screen.
GE Healthcare became aware that some users requested a Field Service Engineer change the dose value display from AKR/CAK to DAP. This configuration does not comply with federal regulations requiring specific dose display for fluoroscopic equipment manufactured after June 10, 2006.
No, the recall does not require stopping use. The issue is a regulatory compliance matter that can be addressed by changing the display settings.
Check if your system displays AKR/CAK instead of DAP. If so, contact GE Healthcare for guidance on correcting the display settings.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2872-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-2872-2020 from GE Healthcare. 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.
