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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 Firm July 06, 2007
Date Posting Updated July 12, 2007
Recall Status1 Terminated 3 on February 01, 2013
Recall Number Z-0990-2007
Recall Event ID 38339
510(K)Number K024012  
Product Classification fluoroscopic x-ray - Product Code JAA
Product GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
Code Information Serial numbers: 8S-2329, 8S-3288-H, 8S-7232-MH, 89-3562.
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
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 4 units
Distribution Worldwide, including USA, France, Singapore, Sweden, and Switzerland.
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
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