Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 1/31/2018
Class lI:

PRODUCT

Syngo Imaging version V31 (model # 10014063) is 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. It supports the physician in diagnosis and treatment planning.
Recall Number Z-0405-2018

REASON
Siemens is releasing a letter to inform about potential data loss relevant to diagnosis.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 7/25/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
36

DISTRIBUTION
Nationwide

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