Company: Fujifilm Medical Systems U.S.A., Inc.
Date of Enforcement Report: 4/7/2021
Synapse PACS – Radiological Image Processing System – Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Recall Number: Z-1348-2021
The wrong patient information may be displayed in the viewer or PowerJacket.
Fujifilm Medical Systems U.S.A., Inc. on 3/2/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
U.S. Nationwide and International