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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 Recall
Magnetom Espree Sytem with Swiveling OR Table
see related information
Date Posted February 05, 2008
Recall Status1 Terminated on February 05, 2008
Recall Number Z-0518-2008
Recall Event ID 45986
Premarket Notification
510(K) Number
K041112 
Product Classification System, Nuclear Magnetic Resonance Imaging - 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, Pennsylvania 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
DESIGN: Device 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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