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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 FirmSeptember 13, 2006
Date PostedOctober 25, 2006
Recall Status1 Terminated 3 on August 13, 2009
Recall NumberZ-0041-2007
Recall Event ID 36400
510(K)NumberK041931 
Product Classification Fluoroscopic X-ray system. - Product Code JAA
ProductGE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.
Code Information Catalog Numbers 887208 and 887210. Serial numbers E9-0002-G, E9-0004-G, E9-0014-G, E9-0032-G, E9-0035-G, E9-0036-G, E9-0040-G, E9-0041-G, E9-0042-G, ES-0002-G, ES-0003-G, ES-0013-G, ES-0014-G, ES-0015-G, ES-0016-G, ES-0018-G, ES-0020-G, ES-0021-G, ES-0023-G, ES-0024-G, ES-0025-G, ES-0026-G, ES-0027-G, ES-0028-G, ES-0031-G, ES-0032-G, ES-0033-G, ES-0034-G, ES-0035-G, ES-0040-G, ES-0041-G, ES-0042-G, ES-0043-G, ES-0044-G, ES-0081-G, ES-0082-G, ES-0083-G, ES-0084-G, ES-0085-G, ES-0086-G.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact
801-328-9300
Manufacturer Reason
for Recall		Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.
FDA Determined
Cause 2		Other
ActionConsignees will be notified by letter beginning 10/16/2006.
Quantity in Commerce40 units
DistributionFL, GA, IL, IN, LA, MA, MD, MO, NH, NJ, PA, TX, UT. Includes one VA facility in PA. China, France.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAA
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