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U.S. Department of Health and Human Services

Class 2 Device Recall GE OEC 9900 Elite Fluoroscopic xray system

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  Class 2 Device Recall GE OEC 9900 Elite Fluoroscopic xray system see related information
Date Initiated by Firm June 12, 2007
Date Posted June 30, 2007
Recall Status1 Terminated 3 on November 01, 2011
Recall Number Z-0848-2007
Recall Event ID 38279
510(K)Number K041931  
Product Classification Fluoroscopic x-ray system - Product Code JAA
Product GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
Code Information Serial numbers: E2-0155, E2-0156, E2-0157, E2-0164, E2-0167, E2-0168, E2-0170 thru E2-0234, E2-0235-C, E2-0236 thru E2-0257, E2-0259, E2-7048-MH, E2-7050-MH, E2-7051-MH, E2-7058-MH, E2-7059-MH, E2-7060-MH, E2-7061-MH, E2-7062-MH, E2-7064-MH, E2-7065-MH, E2-7066-MH, E2-7067-MH, E2-7068-MH, E2-7069-CMH, E2-7070-MH, E2-7071-MH, E2-7072-MH, E2-7073-MH, E2-7074-MH, E2-7076-MH, E2-7077-CMH, E9-0037, E9-0085, E9-0088, E9-0089-G, E9-0090, E9-0093, E9-0094, E9-0095, E9-0098 thru E9-0103, E9-0108 thru E9-0153, E9-0155, E9-0156, E9-0157, E9-0158, E9-0159, E9-0162, E9-0163, E9-0164, E9-0165, E9-0170, E9-0171, E9-0172, E9-0173, E9-0178, E9-0183, ES-0041-G, ES-0069, ES-0071, ES-0072, ES-0078, ES-0084-G, ES-0086-G, ES-0087, ES-0088, ES-0089, ES-0090, ES-0092-CH, ES-0096, ES-0097, ES-0098, ES-0099-CH, ES-0101-CH, ES-0103, ES-0104, ES-0106 thru ES-0130, ES-0131-H, ES-0132 thru ES-0154, ES-0155-H, ES-0156, ES-0157, ES-0158, ES-0159, ES-0160, ES-0162-G thru ES-0167-G, ES-0169-CH, ES-0170, ES-0171, ES-0172, ES-0173, ES-0175, ES-0176, ES-0177, ES-0178, ES-0184, ES-7018-MH, ES-7026-CMH thru ES-7031-CMH, ES-7032-MH, ES-7033-CMH, ES-7034-CMH, ES-7035-CMH, ES-7036-CMH.
Recalling Firm/
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact
Manufacturer Reason
for Recall
X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
FDA Determined
Cause 2
Action Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.
Quantity in Commerce 295 units
Distribution Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.