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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65603
Product Type Devices
Status Ongoing
Recalling Firm Siemens Medical Solutions USA, Inc
City Malvern
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278. Class II 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 when sDIS matching rules are in effect. The risk is that a study may be missing some of its images and/or DICOM SR objects and there is no indication to the user that images and/or SR objects are missing from the study. 9 Z-1859-2013