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U.S. Department of Health and Human Services

Class 2 Device Recall Mobile fluoroscopic xray unit.

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 Class 2 Device Recall Mobile fluoroscopic xray unit.see related information
Date Initiated by FirmJuly 06, 2007
Date PostedJuly 12, 2007
Recall Status1 Terminated 3 on February 01, 2013
Recall NumberZ-0989-2007
Recall Event ID 38339
510(K)NumberK041931 
Product Classification fluoroscopic x-ray - Product Code JAA
ProductGEHC 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
For Additional Information Contact
801-328-9300
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.
FDA Determined
Cause 2		Other
ActionConsignees 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 Commerce22 units
DistributionWorldwide, including USA, France, Singapore, Sweden, and Switzerland.
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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