Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Synapse PACS Software Version 7.4.x Recalled by FUJIFILM Healthcare Americas Corporation Due to The incorrect computed patient age is showing in...

Date: February 11, 2025
Company: FUJIFILM Healthcare Americas Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact FUJIFILM Healthcare Americas Corporation directly.

Affected Products

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.

Quantity: 104 units (69 US, 35 OUS)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 30 states: AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MS, MO, NJ, NY, NC, OH, OK, OR, TN, TX, VT, WA, WV, WI, WY

Affected (30 states)Not affected

About FUJIFILM Healthcare Americas Corporation

FUJIFILM Healthcare Americas Corporation has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report