07

Feb

2018

Cl II Syngo.plaza PACS

0

Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 2/7/2018
Class lI:

PRODUCT

Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
Recall Number Z-0495-2018

REASON
Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 8/18/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
47

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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