510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1705-2008

OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800...

GE Healthcare / initiated 2008-04-15 / Terminated / root cause: design
FDA source (opens on fda.gov)

OEC Medical Systems, Inc began a recall of 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... on . The reason FDA records is "Use of existing four-pedal footswitch on a different machine may cause various operational errors". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1705-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
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.
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall
Use of existing four-pedal footswitch on a different machine may cause various operational errors.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
78 units
Distribution
Nationwide, including one VA facility in FL. No military or foreign distribution.
Product codes and lots
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.