# FDA recall Z-1407-2025

> **FUJIFILM Healthcare Americas Corporation** · Class II · device recall initiated 2025-02-11.

## 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 for recall

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

## Distribution

Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY.  International: Australia, Belgium, Brazil, France, Germany, Portugal, UK

## Key facts

- **Recall number:** Z-1407-2025
- **Recalling firm:** FUJIFILM Healthcare Americas Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-11
- **Report date:** 2025-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lexington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1407-2025

## Citation

> AI Analytics. FDA recall Z-1407-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1407-2025. Source: US FDA. Licensed CC0.

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