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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 Recall
Mobile fluoroscopic xray unit.
see related information
Date Posted July 12, 2007
Recall Status1 Open
Recall Number Z-0990-2007
Recall Event ID 38339
Premarket Notification
510(K) Number
K024012 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - 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, Utah 84116-2862
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
DESIGN: Software Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS
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