FDA Device recall Z-0975-2017
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surg…
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surg… by Ge Oec Medical Systems, citing GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0975-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-19 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
The OEC 9900 Elite mobile fluoroscopy system 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 discretionOEC 9900 Elite. MDL Numbers: D148942, D155043
Reason
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
Identifiers
| code_info | Manufactured between 1/1/16 to 11/1/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Ge Oec Medical Systems
- OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile
FDA Device · Class II · 2024-12-25 · Ge Oec Medical Systems - OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile
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-0975-2017%22
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