Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/23/2016
Class lI:
PRODUCT
Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.
Recall Number Z-1183-2016
REASON
Siemens’ conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 3/17/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
228 units
DISTRIBUTION
US Distribution
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