FDA Device recall Z-1462-2014
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film image…
- FDA Device
- Class II
- terminated
- Published 2014-04-23
On 2014-04-23 the FDA classified a Class II recall of The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film image… by Ge Oec Medical Systems, citing GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1462-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-31 |
| Published | 2014-04-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | n/a |
Product
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
Reason
GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.
Identifiers
| code_info | Model Numbers - OEC 9900 Elite |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Ge Oec Medical Systems
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FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC Flexiview 8800 Systems with 9-inch Image Intensifier
FDA Device · Class II · 2023-08-09 · Ge Oec Medical Systems
All Ge Oec Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1462-2014%22
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