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U.S. Department of Health and Human Services

Class 2 Device Recall Sienet Magicstore

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  Class 2 Device Recall Sienet Magicstore see related information
Date Initiated by Firm May 02, 2007
Date Posted June 05, 2007
Recall Status1 Terminated 3 on September 17, 2008
Recall Number Z-0890-2007
Recall Event ID 37997
510(K)Number K920310  
Product Classification Digital Image Communications/Processing system - Product Code LMD
Product Sienet MagicStore. Radiological Digital Image Communications System
Code Information Model number 7502052 Serial numbers 1793, 1804, 1867, 1920, 1966, 1968, 1983, 2055, 2099, 2527, 2601, 2610, 2618, 2632, 2635, 2638, 2678, 2686, and 2689. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
610-448-4500
Manufacturer Reason
for Recall		 System could crash and result in data loss.
FDA Determined
Cause 2		 Other
Action The recalling firm issued a Safety Advisory letter to their customers (May 2, 2007) to inform them of the problem. A company representative will be contacting the customers to arrange for replacement of the RAID component.
Quantity in Commerce 19 units
Distribution The products were shipped to medical facilities in CA, CO, FL, MS, NH, NJ, NY, and WA.
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 = LMD and Original Applicant = SIEMENS GAMMASONICS, INC.
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