Jul

2016

Cl II Syngo.via

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 7/27/2016
Class lI:

PRODUCT

Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images
Recall Number Z-2245-2016

REASON
Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 6/23/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
50 units

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 Syngo.via

Amy Sellers

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