Cl II Syngo.via

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 7/27/2016
Class lI:

PRODUCT

Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images
Recall Number Z-2245-2016

REASON
Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 6/23/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
50 units

DISTRIBUTION
Nationwide

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