Jun

2015

Cl II Siemens Syngo.via and Syngo.x

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 6/10/2015
Class lI:

PRODUCT

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Recall Number Z-1705-2015

REASON
measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 5/15/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
167

DISTRIBUTION
Nationwide

___________________________________

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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Cl II Siemens Syngo.via and Syngo.x

Amy Sellers

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