# FDA recall Z-0918-2021

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2020-12-11.

## Product

FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage:  intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

## Reason for recall

The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.

## Distribution

US Nationwide distribution in the state of MD.

## Key facts

- **Recall number:** Z-0918-2021
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-11
- **Report date:** 2021-02-03
- **Termination date:** 2021-11-17

- **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-0918-2021

## Citation

> AI Analytics. FDA recall Z-0918-2021. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0918-2021. Source: US FDA. Licensed CC0.

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