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U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Harmony

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  Class 2 Device Recall Magnetom Harmony see related information
Date Initiated by Firm July 28, 2004
Date Posted August 24, 2004
Recall Status1 Terminated 3 on January 25, 2005
Recall Number Z-1397-04
Recall Event ID 29831
510(K)Number K970852  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Magnetom Harmony MRI System Model number 5751438
Code Information Serial number 15002
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
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 2
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 1 unit
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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.