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Class 2 Device Recall GE OEC 9900 Elite Fluoroscopic Xray system. |
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Date Initiated by Firm |
September 13, 2006 |
Date Posted |
October 25, 2006 |
Recall Status1 |
Terminated 3 on August 13, 2009 |
Recall Number |
Z-0041-2007 |
Recall Event ID |
36400 |
510(K)Number |
K041931
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Product Classification |
Fluoroscopic X-ray system. - Product Code JAA
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Product |
GE 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
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For Additional Information Contact |
801-328-9300
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Manufacturer Reason for Recall |
Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.
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FDA Determined Cause 2 |
Other |
Action |
Consignees will be notified by letter beginning 10/16/2006. |
Quantity in Commerce |
40 units |
Distribution |
FL, GA, IL, IN, LA, MA, MD, MO, NH, NJ, PA, TX, UT. Includes one VA facility in PA. China, France. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
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