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U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Trio

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  Class 2 Device Recall Magnetom Trio see related information
Date Initiated by Firm October 12, 2006
Date Posted November 29, 2006
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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