Class 3 Device Recall Magnetom

• Date Initiated by Firm: November 27, 2002
• Date Posted: July 03, 2003
• Recall Status: Terminated on May 11, 2004
• Recall Number: Z-0976-03
• Recall Event ID: 26421
• 510(K)Number: K012495
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Magnetom Symphony/Sonata, OR Table.
• Code Information: Serial Numbers 021107 and 021941.
• 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: OR Table stops during the transfer of the table to the MR system and will not move.
• FDA Determined Cause: Other
• Action: Customer Advisory Letter, number 01/2002 titled ''Potential Fault condition of the OR-Table in combination with Magnetom Symphony/Sonata' was sent out to the 2 hospitals in November, 2002.
• Quantity in Commerce: 2
• Distribution: CA, 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 = LNH