Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 2/7/2018
Class lI:
PRODUCT
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
Recall Number Z-0495-2018
REASON
Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 8/18/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
47
DISTRIBUTION
Nationwide
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