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U.S. Department of Health and Human Services

Class 2 Device Recall Syngo MultiModality WorkPlace

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 Class 2 Recall
Syngo MultiModality WorkPlace
see related information
Date Posted December 03, 2008
Recall Status1 Terminated on September 23, 2009
Recall Number Z-0324-2009
Recall Event ID 50085
Premarket Notification
510(K) Number
K010938 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.
Code Information Serial numbers: 7826, 7951, 7981, 7989, 8011, 8056, 8109, 8161, 8209, 8213, 8312, 8341, 8361, 8382, 8393, 8405, 8409, 8413, 8430, 8433, 8442, 8511, 8526, 8536, 8548, 8637, 8638, 8657, 8670, 8688, 8701, 8707, 8771, 8772, 8773, 8774, 8781, 8793, 8814, 8829, 8862, 8879, 8881, 9043, 9044, 9046, 9080, 9097, 9081, 9105, 9137, 9149, 9152, 9154, 9188, 9191, 9206, 9218, 9219, 9232, 9235, 9243, 9244, 9248, 9283, 9291, 9316, 9322, 9351, 9360, 9361, 9368, 9388, 9394, 9395, 9413, 9414, 9416, 9417, 9429, 9445, 9446, 9452, 9488, 9498, 9504, 9508, 9520, 9521, 9532, 9536, 9568, 9723, 9725, 9729, 9737, 15154, 15510, 15512, 20903, 20904, 20907, 20917, 20928, 20931, 20937, 20939, 20940, 20941, 20942, 20943, 20944, 20945, 20946, 20948, 20955, 20956, 20957, 20961, 20962, 20972, 20974, 20977, 21017, 21018, 21020, 21021, 21025, 21028, and 21030.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355-1406
For Additional Information Contact Michael Van Ryn
610-448-4500
Manufacturer Reason
for Recall
Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.
FDA Determined
Cause 2
DESIGN: Software Design
Action The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08.
Quantity in Commerce 130 units
Distribution Nationwide Distribution.
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 = LLZ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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