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Class 2 Device Recall Magnetom Harmony syngo |
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Date Initiated by Firm |
December 01, 2007 |
Date Posted |
March 25, 2008 |
Recall Status1 |
Terminated 3 on October 01, 2012 |
Recall Number |
Z-1044-2008 |
Recall Event ID |
46245 |
510(K)Number |
K970852
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Product Classification |
Nuclear Magnetic Resonance Imaging System - Product Code LNH
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Product |
Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA, Malvern PA, 19355 |
Code Information |
Serial Numbers: 11006, 11044, 11065, 11090, 11102, 11112, 11115, 11127, 11157, and 11162. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
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For Additional Information Contact |
Catherine Moffa 610-448-4500
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Manufacturer Reason for Recall |
Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
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FDA Determined Cause 2 |
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 |
10 units |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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