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U.S. Department of Health and Human Services

Class 2 Device Recall syngo Dynamics

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 Class 2 Recall
syngo Dynamics
see related information
Date Posted August 01, 2013
Recall Status1 Open
Recall Number Z-1859-2013
Recall Event ID 65603
Premarket Notification
510(K) Number
K102150 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo® Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo® Dynamics is not intended to be used for reading mammography images.
Code Information Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Siemens Customer Service
610-219-6300
Manufacturer Reason
for Recall
Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with modality device configured to end study at association close. Images or DICOM SR objects sent from a modality device to syngo Dynamics may not be saved when the modality is configured at syngo Dynamics to end study at association close, and whe
FDA Determined
Cause 2
DESIGN: Software Design
Action Siemens sent a Customer Safety Advisory Notice dated June 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1) With sDIS implemented, use the DICOM Modality List (DMWL), without sDIS matching rules enabled OR 2) Do not implement sDIS. Update instructions were also provided. The reported issue will be resolved in a modification to syngo Dynamics version 9.5 and syngo Dynamics VA10A which will be released in the near future. We regret any inconvenience that this may cause , and we thank you in advance for your understanding. For further questions please call (610) 219-6300.
Quantity in Commerce 9
Distribution US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
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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