May

2014

Siemens Syngo Dynamics Cl II

Company Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/21/2014
Class lI:

PRODUCT

Syngo Dynamics Product Usage: Syngo Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. Recall Number Z-1613-2014

REASON
Siemens Medical Solutions USA, Inc. has become aware of a potential issue with the Syngo Dynamics v9.5 system with a specific set of serial numbers. Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA on 4/3/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
50

DISTRIBUTION
Nationwide

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About the author

Amy Sellers

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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Siemens Syngo Dynamics Cl II

Amy Sellers

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