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U.S. Department of Health and Human Services

Class 2 Device Recall Imageintensified fluoroscopic xray system.

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 Class 2 Device Recall Imageintensified fluoroscopic xray system.see related information
Date Initiated by FirmJanuary 15, 2007
Date PostedFebruary 15, 2007
Recall Status1 Terminated 3 on December 09, 2011
Recall NumberZ-0515-2007
Recall Event ID 37191
510(K)NumberK993687 
Product Classification fluoroscopic x-ray system - Product Code JAA
ProductOEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
Code Information Model Numbers 882082-01, 882082-02, 886765-01. Units with manufactured dates between 03/2003 and 08/2006.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information ContactMs. Karen Tolson
847-501-1884
Manufacturer Reason
for Recall		Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.
Quantity in Commerce277 units
DistributionWorldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.
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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