Nov

2017

Siemens Syngo.plaza PACS Cl II

CompanySiemens Medical Solutions USA, Inc
Date of Enforcement Report 11/29/2017
Class lI:

PRODUCT

Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Recall Number Z-0168-2018

REASON
Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 6/22/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2 units

DISTRIBUTION
MN

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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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Siemens Syngo.plaza PACS Cl II

Amy Sellers

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