Apr

2017

Cl II Siemens Syngo.x

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 4/5/2017
Class lI:

PRODUCT

Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Recall Number Z-1688-2017

REASON
Software changes now available to address several issues

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 3/6/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
104 systems

DISTRIBUTION
Nationwide Distribution

___________________________________

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.x

Amy Sellers

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