Apr

2016

Cl II Siemens Picture Archiving and Communication

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/13/2016
Class lI:

PRODUCT

A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Recall Number Z-1349-2016

REASON
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 1/18/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
49 systems

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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Cl II Siemens Picture Archiving and Communication

Amy Sellers

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