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U.S. Department of Health and Human Services

Class 3 Device Recall Magnetom Trio

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  Class 3 Device Recall Magnetom Trio see related information
Date Initiated by Firm December 18, 2003
Date Posted February 10, 2004
Recall Status1 Terminated 3 on November 09, 2004
Recall Number Z-0521-04
Recall Event ID 28046
510(K)Number K013586  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device
Code Information Model #7387074 - Serial #''s: 20501 through 20508, 20510 through 20524, and 20550 through 20570. Model #7106441 - Serial # 20500
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
Manufacturer Reason
for Recall
tissue roll can become magnetic
FDA Determined
Cause 2
Action The recalling firm has issued Updated Instructions to replace the stainless steel tissue roll holder. The recalling firm''s representatives are visiting each account to replace the tissue roll holder.
Quantity in Commerce 16 units
Distribution The product was shipped to medical facilities in CA, CT, DC, FL, GA, IL, IN, KS, KY, MA, MD, MN, NC, NY, OH, OR, PA, TX, and UT.
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 SYSTEMS, INC.