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Class 2 Device Recall Xray system |
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Date Initiated by Firm |
May 12, 2003 |
Date Posted |
June 21, 2003 |
Recall Status1 |
Terminated 3 on July 07, 2011 |
Recall Number |
Z-0946-03 |
Recall Event ID |
26383 |
510(K)Number |
K914446
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Product Classification |
System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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Product |
Uroview 2500 X-ray System |
Code Information |
Serial numbers beginning with M2 and M9. |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems,Inc 384 Wright Brothers Drive Salt Lake City UT 84116
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For Additional Information Contact |
801-536-4668
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Manufacturer Reason for Recall |
Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
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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 |
263 units |
Distribution |
Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = JAA and Original Applicant = OEC-DIASONICS, INC.
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