Class 2 Device Recall Siemens Uroskop

• Date Initiated by Firm: November 27, 2002
• Date Posted: January 30, 2003
• Recall Status: Terminated on January 10, 2005
• Recall Number: Z-0493-03
• Recall Event ID: 25329
• 510(K)Number: K923049
• Product Classification: Table, Radiographic, Tilting - Product Code IXR
• Product: Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top.
• Code Information: Uroskop D1 -- Model #9785023 Uroskop D2/D3 -- Model #9785015
• Recalling Firm/ Manufacturer: Siemens Medical Systems Inc; 186 Wood Ave So; Iselin NJ 08830
• For Additional Information Contact: Roland Richter; 732-321-4835
• Manufacturer Reason for Recall: There is unintended system movement or unwanted automatic movement of the tabletop.
• FDA Determined Cause: Other
• Action: Siemens personal will install Host Software VA00F and Generator Host Software VE00D on affected Uroskop units. Update instructions were sent to users November 27,2002 and December 7, 2002.
• Quantity in Commerce: 13
• Distribution: Product was distributed to 6 hospitals nationwide and 5 government hospitals. Internationally, the tables were distributed to Germany, Netherlands, Italy , Luxembourg, Sweden, Austria, Switzerland, Slovakia, Hungary, Ukraine, Russia, Turkmenistan, South Africa, Canada, Malaysia, Japan, and Taiwan.
• 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 = IXR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.