Class 2 Device Recall

• Date Initiated by Firm: August 11, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated 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
• FEI Number: 2082981
• 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: 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.