23
Mar
2016

Cl II Siemens Syngo Dynamics

0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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