Recall – Wrong patient information may be displayed on PACS viewer

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.