04

Apr

2018

Siemens Syngo.via software Cl II

0

Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 4/4/2018
Class lI:

PRODUCT

Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
Recall Number Z-1261-2018

REASON
When the archiving configuration is changed, data received/created after the upgrade may be flagged as “Not to be archived”. This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged “Not to be archived” must be manually prevented from being deleted by either clinical administrator or service engineer.

Siemens Medical Solutions USA, Inc, Malvern PA.on 1/10/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
165 units

DISTRIBUTION
Medical device software which needs to be installed.

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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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