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Class 2 Device Recall Mobile fluoroscopic xray unit. |
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Date Initiated by Firm |
July 06, 2007 |
Date Posted |
July 12, 2007 |
Recall Status1 |
Terminated 3 on February 01, 2013 |
Recall Number |
Z-0989-2007 |
Recall Event ID |
38339 |
510(K)Number |
K041931
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Product Classification |
fluoroscopic x-ray - Product Code JAA
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Product |
GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. |
Code Information |
Serial numbers: E2-0083, E2-0096, E2-0100, E2-0122, E2-0139, E2-0141, E2-0144, E2-0153, E2-7040-MH, E2-7054-MH, E2-7062-MH, E2-7070-MH, E9-0012, E9-0029, E9-0059, E9-0085, E9-0106, E9-0114, E9-0170, ES-0052, ES-0159, ES-0171. |
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 |
The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available. |
Quantity in Commerce |
22 units |
Distribution |
Worldwide, including USA, France, Singapore, Sweden, and Switzerland. |
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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