Jul

2016

Cl II Siemens Syngo.plaza

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 7/6/2016
Class lI:

PRODUCT

Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers – 10863171, 10863172, 10863173,
Recall Number Z-2088-2016

REASON
Software error in previous software versions in which two references for the same image may exist in the database.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 5/92016. Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
74 systems

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.plaza

Amy Sellers

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