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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9900 Elite

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 Class 2 Recall
OEC 9900 Elite
see related information
Date Posted September 01, 2008
Recall Status1 Open
Recall Number Z-1706-2008
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 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.
Code Information Serial numbers: E2-0034, E2-0088, E2-0109, E2-0258, E2-0270, E2-7019-MH, E2-7020-MH, E2-7034-CMH, E2-7037-MH, E2-7043-MH, E9-0029, E9-0047, E9-0169, E9-0171, E9-0172, E9-0173, E9-0177, ES-0113, ES-7015-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 25 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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