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U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Espree Sytem with Swiveling OR Table

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  Class 2 Device Recall Magnetom Espree Sytem with Swiveling OR Table see related information
Date Initiated by Firm November 05, 2007
Date Posted February 05, 2008
Recall Status1 Terminated 3 on February 05, 2008
Recall Number Z-0518-2008
Recall Event ID 45986
510(K)Number K041112  
Product Classification Magnetic Resonance Imaging System, - Product Code LNH
Product Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA
Code Information Serial Numbers 1002, 1003, 1004, and 1007
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Catherine Moffa
610-448-1774
Manufacturer Reason
for Recall		 Table may experience a deadlock situation
FDA Determined
Cause 2		 Software design
Action The recalling firm issued a Customer Safety Advisory to affected customers per Update Instructions MR031/07/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. The recalling firm has also released the software update to correct the issue via Update Instructions MR034/07/S. Notifications were issued on or about November 5, 2007.
Quantity in Commerce 4 units
Distribution The products were shipped to medical facilities in TX and NY.
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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