Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 7/6/2016
Class lI:
PRODUCT
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers – 10863171, 10863172, 10863173,
Recall Number Z-2088-2016
REASON
Software error in previous software versions in which two references for the same image may exist in the database.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 5/92016. Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
74 systems
DISTRIBUTION
Nationwide
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