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U.S. Department of Health and Human Services

Class 2 Device Recall GE OEC 2800 mobile Fluoroscopic xray system

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 Class 2 Recall
GE OEC 2800 mobile Fluoroscopic xray system
see related information
Date Posted June 30, 2007
Recall Status1 Open
Recall Number Z-0852-2007
Recall Event ID 38279
Premarket Notification
510(K) Number
K024012 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
Code Information Serial numbers: P4-0665-R, P4-0666-L, P4-0679-R, P4-0685-L, P4-0686-L, P4-0694-R, P4-0696-L, P4-0701-R, P4-0702-R, P4-0717-L, P4-0723-R, P4-0730-L, P6-0695-R, P6-0699-R, P6-0700-R, P6-0709-R, P6-0711-L, P6-0712-R, P6-0714-L, P6-0715-L, P6-0718-R, P6-0719-L, P6-0721-L, P6-0724-R, P6-0726-L.
Recalling Firm/
Manufacturer
GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
Manufacturer Reason
for Recall
X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.
Quantity in Commerce 25 units
Distribution Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.
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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