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U.S. Department of Health and Human Services

Class 2 Device Recall syngo.plaza

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 Class 2 Recall
syngo.plaza
see related information
Date Posted August 27, 2012
Recall Status1 Terminated on January 24, 2014
Recall Number Z-2275-2012
Recall Event ID 62679
Premarket Notification
510(K) Number
K101666 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Code Information Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall
There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm initiated their recall/correction of this device on July 18, 2012 by sending a "Customer Safety Advisory Notice" letter, dated July 12, 2012, to their consignees. The letter identified the affected product along with the malfunction. It also discussed the steps the user can take to avoid the issue. Users were asked to not use the mentioned functions for images from those modalities until the issue was resolved and the system was updated with the software version containing the solution. Users were to contact their local Siemens Service in order to plan for the updated software version that will resolve the issue. Additionally, users should place the safety advisory notice in the system's instructions for use, and personnel should be instructed accordingly and maintain awareness. If the device was sold and is no longer in the users' possession, the notice should be forwarded to the new owner and the firm should be notified of the new owner.
Quantity in Commerce 14
Distribution Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
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 AG, MEDICAL SOLUTIONS
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