Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 7/8/2015
Class lI:
PRODUCT
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging 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.
Recall Number Z-1972-2015
REASON
Siemens became aware that during certain clinical workflows minor safety issues may occur. No adverse events reported.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 5/11/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
5
DISTRIBUTION
US in the states of NC and NE
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