Company: Fujifilm Medical Systems U.S.A., Inc.
Date of Enforcement Report: 4/7/2021
Class II

PRODUCT

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

REASON

The wrong patient information may be displayed in the viewer or PowerJacket.

RECALLING FIRM/MANUFACTURER

Fujifilm Medical Systems U.S.A., Inc. on 3/2/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

839 systems

DISTRIBUTION

U.S. Nationwide and International