# FDA recall Z-0282-2021

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2020-09-11.

## Product

Synapse PACS Software Version 5.6.1 - 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

FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.

## Distribution

US Nationwide distribution including in the state of Minnesota.

## Key facts

- **Recall number:** Z-0282-2021
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-11
- **Report date:** 2020-10-28
- **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-0282-2021

## Citation

> AI Analytics. FDA recall Z-0282-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0282-2021. Source: US FDA. Licensed CC0.

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