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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 11, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 26, 2003
Recall Number Z-0162-04
Recall Event ID 27677
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product URO PRO Plus Digital Urology Imaging System
Code Information Serial Numbers:  UR2003-006 UR2001-006 UR2002-010 UR2003-004 UR2001-2R03 
Recalling Firm/
Manufacturer
Medstone International Inc
100 Columbia 100
Aliso Viejo CA 92656
Manufacturer Reason
for Recall
X-ray tube arm and collimator fell and fractured patient's ribs.
FDA Determined
Cause 2
Other
Action An initial safety alert was sent to sites on 7/29/2003 to pre-announce repairs and advise them to not use the equipment. A second safety alert was sent on 8/11/03 to confirm repair dates. Repairs were completed 8/19,2003.
Quantity in Commerce 5 units
Distribution NM, NV, WA, CA.
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.
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