May

2016

Cl II Syngo Dynamics; Kinetdx Picture Archiving

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 5/11/2016
Class lI:

PRODUCT

Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Recall Number Z-1601-2016

REASON
Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 4/14/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
84 units

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 Syngo Dynamics; Kinetdx Picture Archiving

Amy Sellers

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