Class 2 Device Recall Siregraph CF XRay System

• Date Initiated by Firm: June 07, 2004
• Date Posted: September 18, 2004
• Recall Status: Terminated on August 18, 2005
• Recall Number: Z-1475-04
• Recall Event ID: 29967
• 510(K)Number: K960266
• Product Classification: System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
• Product: Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466033
• Code Information: Serial numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1572, 1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter; 610-448-1777
• Manufacturer Reason for Recall: X-ray tube movement when table is tilted more than 90 degrees
• FDA Determined Cause: Other
• Action: The recalling firm issued a Customer DAfety Advisory letter dated 6/7/04 to the hospitals. The letter informs them of the potential problem and provides preventative measures to avoid its occurance.
• Quantity in Commerce: 15 units
• Distribution: The products were shipped to medical facilities in FL, IL, MI, NH, NJ, PA, and TX.
• 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