FDA Device recall Z-2038-2012
OEC 9800
- FDA Device
- Class I
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class I recall of OEC 9800 by Ge Oec Medical Systems, citing please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2038-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2008-02-22 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Oec Medical Systems |
| Distribution | n/a |
Product
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
Reason
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.
Identifiers
| code_info | 8S-1663 , 8S-2887 , 89-3119 , 89-0098 , 8S-0152-C , 89-0540 , 82-1252, 82-1519, 89-2326 , 89-1204 , 89-3272, 89…8S-1663 , 8S-2887 , 89-3119 , 89-0098 , 8S-0152-C , 89-0540 , 82-1252, 82-1519, 89-2326 , 89-1204 , 89-3272, 89-3273 , 8S-0258 , 82-0678, 82-1884 , 8S-2321 , 82-2042 , 82-3210 , 8S-0533 , 8S-1077 , 89-0910 , 82-0139, 82-3871, 89-1757 , 89-3298 , 89-3026 , 8S-2299, 8S-2857 , 89-2043 , 89-2533 , 89-2463 , 82-0356-RC , 8S-2120 , 89-1896 , 8S-7152-MH , 8S-7190-MH , 8S-3246 , 8S-0289 , 89-1626 , 8S-0625 , 8S-1301 , 8S-1920 , 89-1025 , 8S-1838 , 8S-1367 , 8S-1627 , 89-1112 , 8S-0076-RC , 8S-0508, 8S-1946 , 8S-3073, 8S-3105 , 8S-2324-C , 8S-0073 , 8S-0180 , 8S-2237 , 82-0126, 82-3040, 82-3710 , 8S-2647 , 89-2319 , 89-3105 , 82-2560, 89-0285, 8S-1310 , 8S-2124 , 8S-1626 , 89-1486 , 82-3426 , 82-0875 , 8S-2566 , 89-0955 , 82-1801 , 82-1568 , 82-3682 , 89-0073, 89-1118, 89-1147 , 8S-0706 , 8S-0622, 8S-0772 , 8S-1139 , 8S-2182, 8S-2183 , 8S-2184 , 8S-0567 , 8S-1974 , 89-0454, 82-1606, 82-1870, 82-2533, 82-7080-MH, 89-0039, 89-1607, 89-21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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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-2038-2012%22
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