Company: Fujifilm Medical Systems U.S.A., Inc.
Date of Enforcement Report: 10/28/2020
Class II
PRODUCT
Synapse PACS Software Version 5.6.1 – Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Recall Number: Z-0282-2021
REASON
FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere – other density tools are not affected.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical Systems U.S.A., Inc. on 9/11/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
U.S. Nationwide