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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-0989-2007
Recall Event ID 38339
Premarket Notification
510(K) Number
K024012 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GEHC OEC 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, 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 22 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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