OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
This recall has been terminated (originally issued September 1, 2008).
- Company
- Oec Medical Systems, Inc
- Recall Initiated
- April 15, 2008
- Posted
- September 1, 2008
- Terminated
- December 21, 2011
- Recall Number
- Z-1705-2008
- Quantity
- 78 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Use of existing four-pedal footswitch on a different machine may cause various operational errors.
Distribution
Nationwide, including one VA facility in FL. No military or foreign distribution.
Lot / Code Info
Serial numbers: 82-0886, 82-1387, 82-1471, 82-1827, 82-1837, 82-2088, 82-2091-C, 82-2219, 82-2265, 82-2298, 82-2308, 82-2330, 82-2342, 82-2418, 82-2633, 82-2764, 82-2902, 82-2919, 82-2982, 82-3012-N, 82-3033, 82-3062, 82-3147, 82-3185, 82-3311, 82-3313, 82-3314, 82-3411, 82-3428-E, 82-3509, 82-3510, 82-3576, 82-3739, 82-3763, 82-3765, 82-3830, 82-3880, 82-7106, 82-7179-MH, 89-0014, 89-0017, 89-0938, 89-1128, 89-1451, 89-2212, 89-2402, 89-2773, 89-2989, 89-3078, 89-3083, 89-3164, 89-3301, 89-3356, 89-3487, 8S-0271, 8S-0488, 8S-0974, 8S-1460, 8S-1487, 8S-1508-N, 8S-1582, 8S-1932-N, 8S-2425, 8S-2507, 8S-3054, 8S-3236, 8S-3242, 8S-7141-MH, 8S-7199-MH.
Root Cause
Device Design
Action Taken
Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.