28
Oct
2020

Recall – PACS software reports incorrect value

,
0

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

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