Company: Fujifilm Medical Systems U.S.A., Inc.
Date of Enforcement Report: 7/8/2020
Class II

PRODUCT

Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

Recall Number: Z-2471-2020

REASON

Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis

RECALLING FIRM/MANUFACTURER

Fujifilm Medical Systems U.S.A., Inc. on 5/22/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

135 units

DISTRIBUTION

U.S. Nationwide