# FDA recall Z-0878-2021

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

## Product

Synapse PACS Software Versions 5.1 and higher

## Reason for recall

There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

## Distribution

Software was distributed to medical facilities nationwide throughout the U.S.

## Key facts

- **Recall number:** Z-0878-2021
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-11
- **Report date:** 2021-01-27

- **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-0878-2021

## Citation

> AI Analytics. FDA recall Z-0878-2021. Retrieved 2026-08-23 from https://api.ai-analytics.org/recall/Z-0878-2021. Source: US FDA. Licensed CC0.

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