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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 Firm January 15, 2007
Date Posted February 15, 2007
Recall Status1 Terminated 3 on December 09, 2011
Recall Number Z-0514-2007
Recall Event ID 37191
510(K)Number K993687  
Product Classification fluoroscopic x-ray system - Product Code JAA
Product OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, 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 Contact Ms. Karen Tolson
847-501-1884
Manufacturer Reason
for Recall		 Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall.
FDA Determined
Cause 2		 Other
Action Consignees 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 Commerce 425 units
Distribution Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JAA and Original Applicant = GE DEC MEDICAL SYSTEMS
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