Recall Z-2872-2020 ยท RCC C-Arm Fluoroscopic X-Ray System
Ge Healthcare
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of t
| Date | Aug 27, 2020 (initiated May 8, 2020) |
| Status | Open, Classified |
| Reason | 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 o |
| Root cause | Radiation Control for Health and Safety Act |
| Quantity | 221 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111551 | OEC(R) 9800, OEC(R) 9800 PLUS Ge Oec Medical Systems, Inc., Oct 4, 2011 |
| K120613 | OEC 9900 ELITE Ge Healthcare Surgery GE Oec Medical Systems, Inc., Apr 6, 2012 |
| K122234 | OEC 9900 ELITE Ge Healthcare Surgery GE Oec Medical Systems, Inc., Aug 16, 2012 |
| K132027 | OEC 9800 PLUS Ge Oec Medical Systems, Inc., May 1, 2014 |