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