Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 2/14/2018
Class lI:
PRODUCT
Syngo.plaza systems with SW VB20A, Model Number – 10863171, 10863172, 10863173Product Usage:Syngo.plaza is a Picture Archiving and Communication System (PACS) 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-0524-2018
REASON
When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study. .
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 8/23/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
76
DISTRIBUTION
Nationwide
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