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U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Espree

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  Class 2 Device Recall Magnetom Espree see related information
Date Initiated by Firm August 12, 2005
Date Posted September 09, 2005
Recall Status1 Terminated 3 on July 19, 2006
Recall Number Z-1529-05
Recall Event ID 33308
510(K)Number K041112  
Product Classification unknown device name - Product Code LNN
Product Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165
Code Information Serial numbers 30001 to 30075
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall		 there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore
FDA Determined
Cause 2		 Other
Action The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
Quantity in Commerce 209 units
Distribution The products were shipped to medical facilities and MRI facilities nationwide.
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 = LNN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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