Class 2 Device Recall Magnetom Symphony

• Date Initiated by Firm: July 28, 2004
• Date Posted: August 24, 2004
• Recall Status: Terminated on January 25, 2005
• Recall Number: Z-1399-04
• Recall Event ID: 29831
• 510(K)Number: K971684
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Magnetom Symphony MRI System, Model 7104594
• Code Information: Serial numbers 22009, 22016, and 22081
• 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: An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
• FDA Determined Cause: Other
• Action: The recalling firm issued a Customer Safety Advisory letter via certified mail to their customers per Update Instructions MR028/04/S. The letter informs customers of the potential issue and provides instructions to avoid its occurence.
• Quantity in Commerce: 3 units
• Distribution: The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA.
• 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