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U.S. Department of Health and Human Services

Class 2 Device Recall Sienet Magicstore

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 Class 2 Recall
Sienet Magicstore
see related information
Date Posted June 05, 2007
Recall Status1 Terminated on September 17, 2008
Recall Number Z-0890-2007
Recall Event ID 37997
Premarket Notification
510(K) Number
K920310 
Product Classification System, Digital Image Communications, Radiological - 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, Pennsylvania 19355-1406
For Additional Information Contact Roland Richter
610-448-4500
Manufacturer Reason
for Recall
System could crash and result in data loss.
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 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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