Class 3 Device Recall Siemens

• Date Initiated by Firm: November 27, 2002
• Date Posted: July 19, 2003
• Recall Status: Terminated on October 03, 2006
• Recall Number: Z-1032-03
• Recall Event ID: 26574
• 510(K)Number: K002137
• Product Classification: System, X-Ray, Angiographic - Product Code IZI
• Product: Cathcor/LX/Desktop, System, X-Ray, Angiographic
• Code Information: Serial Numbers:01029, 01033, 01034,01062, 01108, 01110, 01121, 01125, 02048.
• 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: Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
• FDA Determined Cause: Other
• Action: A Customer Safety Advisory Letter was sent via registered mail on 10/30/2002.
• Quantity in Commerce: 9
• Distribution: 5 Hospitals/Clinics in the US.
• 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 = IZI