Cl II software for Syngo Dynamics

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/2/2016
Class lI:

PRODUCT

software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. Recall Number Z-0826-2016

REASON
Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 2/19/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
151

DISTRIBUTION
Nationwide

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