The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical a
FDA device recall Z-2872-2020 · posted 2020-08-27 · Open, Classified
Recall details
- Recalling firm
- Ge Healthcare
- Reason for recall
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- RCC
- Quantity affected
- 221
- Distribution
- Nationwide
- Date initiated
- 2020-05-08
- Date posted
- 2020-08-27
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC 9800 PLUS (K132027) | Ge Oec Medical Systems, Inc. | 2014-05-01 |
| OEC 9900 ELITE (K122234) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-08-16 |
| OEC 9900 ELITE (K120613) | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012-04-06 |
| OEC(R) 9800, OEC(R) 9800 PLUS (K111551) | Ge Oec Medical Systems, Inc. | 2011-10-04 |