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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9800

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 Class 2 Recall
OEC 9800
see related information
Date Posted September 01, 2008
Recall Status1 Open
Recall Number Z-1705-2008
Recall Event ID 47774
Premarket Notification
510(K) Numbers
K021049  K022069  K024012  K041932 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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.
Code Information 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.
Recalling Firm/
Manufacturer
OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Use of existing four-pedal footswitch on a different machine may cause various operational errors.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS
510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
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