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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 Device Recall GE OEC 2800 mobile Fluoroscopic xray systemsee related information
Date Initiated by FirmJune 12, 2007
Date PostedJune 30, 2007
Recall Status1 Terminated 3 on November 01, 2011
Recall NumberZ-0852-2007
Recall Event ID 38279
510(K)NumberK993687 
Product Classification Fluoroscopic x-ray system - Product Code JAA
ProductGE 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 UT 84116-2862
For Additional Information Contact
801-536-4516
Manufacturer Reason
for Recall		X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
FDA Determined
Cause 2		Other
ActionConsignees 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 Commerce25 units
DistributionWorldwide 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 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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