Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 10/19/2016
Class lI:
PRODUCT
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Recall Number Z-0073-2017
REASON
Image data for a patients image may not be correct.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc. Tarrytown, NY on 10.12/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
251 units
DISTRIBUTION
Nationwide
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