Recall Z-1407-2025— FUJIFILM Healthcare Americas Corporation

Name: FDA recall Z-1407-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-11

Class II · Ongoing

Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2025-02-11. It names 2 FDA 510(k) clearances: K190232, K160108. Product: Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.. Reason: The incorrect computed patient age is showing in VX for patients less than 3 months old..

Recalling firm: FUJIFILM Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-02-11
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K190232 — Synapse PACSFujifilm Corporation·cleared 2019-03-26
K160108 — Synapse PACSFujifilm Medical Systems U.S.A, Inc.·cleared 2016-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

Reason for recall

The incorrect computed patient age is showing in VX for patients less than 3 months old.

Data sourced from openFDA. This site is unofficial and independent of the FDA.