Class 2 Device Recall Magnetom Harmony syngo

• Date Initiated by Firm: December 01, 2007
• Date Posted: March 25, 2008
• Recall Status: Terminated on October 01, 2012
• Recall Number: Z-1043-2008
• Recall Event ID: 46245
• 510(K)Number: K970852
• Product Classification: Nuclear Magnetic Resonance Imaging System - Product Code LNH
• Product: Siemens Magnetom Harmony syngo. Model Number: 7106714, Siemens Medical Solutions USA, Malvern PA, 19355
• Code Information: Serial Numbers: 10510, 10555, 10565, 10620,10663, 10665, and 10669
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Catherine Moffa; 610-448-4500
• Manufacturer Reason for Recall: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
• FDA Determined Cause: Device Design
• Action: The firm issued an Update Instruction package to consignees 12/07. As an immediate measure, the recalling firm is initiating field checks of mobile MRI systems per Update Instruction MR039/07/S. This update defines a safety inspection for mobile systems, including checks for potential ice formation and proper configuration of venting assemblies.
• Quantity in Commerce: 7 units
• Distribution: Nationwide Distribution
• 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