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U.S. Department of Health and Human Services

Class 2 Device Recall Xray system

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  Class 2 Device Recall Xray system see related information
Date Initiated by Firm May 12, 2003
Date Posted June 21, 2003
Recall Status1 Terminated 3 on July 07, 2011
Recall Number Z-0947-03
Recall Event ID 26383
510(K)Number K940295  
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Uroview 2600 Uroview System
Code Information Serial numbers beginning with W2 and W9.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems,Inc
384 Wright Brothers Drive
Salt Lake City UT 84116
For Additional Information Contact
801-536-4668
Manufacturer Reason
for Recall		 Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
FDA Determined
Cause 2		 Other
Action A Product Safety Alert letter was sent to all consignees on 5/12/2003 recommending that all hand controls be removed from the units.
Quantity in Commerce 636 units
Distribution Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
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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