Class 2 Device Recall Magnetom Trio

• Date Initiated by Firm: October 12, 2006
• Date Posted: November 29, 2006
• Recall Status: Terminated on April 23, 2008
• Recall Number: Z-0225-2007
• Recall Event ID: 36804
• 510(K)Number: K050200
• Product Classification: magnetic resonance imaging - Product Code LNH
• Product: Magnetom Trio magnetic resonance imaging
• Code Information: Model number 7387074. Serial numbers 20596, 20602, 20613, 20601, 20567, 20557, 20507, 20554, 20559, 20523, 20577, and 20565.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter; 610-448-4500
• Manufacturer Reason for Recall: Possible excessive RF exposure/may burn
• FDA Determined Cause: Other
• Action: The recalling firm has issued a Customer Safety Advisory to affected customers per Update Instructions MR038/06/S. The letter informs customers of the potential issue and instructs them not to use the involved coils until this issue can be corrected.
• Quantity in Commerce: 12 units
• Distribution: Nationwide.
• 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