Class 2 Device Recall Uroskop D1/D2/D3

• Date Initiated by Firm: August 08, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on January 16, 2004
• Recall Number: Z-0009-04
• Recall Event ID: 27023
• 510(K)Number: K923049
• Product Classification: System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
• Product: Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive
• Code Information: Uroskop D1/D2/D3
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Parkway; Malvern PA 19355
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: possible movement of table tilt and table longitudinal
• FDA Determined Cause: Other
• Action: The recalling firm issued Update Instructions SP016/03/S, SP017/03S and SP018/03/S that instruct the Service Engineers to visit each affected system to install the required parts.
• Quantity in Commerce: 34 units
• Distribution: Nationwide. The product was shipped to medical facilities in CA, FL, GA, IL, MD, NC, NJ, NY, OK, PA, SC, TN, TX, VA, WI, and WV.
• 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