# FDA recall Z-2471-2020

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2020-05-22.

## Product

Fujifilm Synapse PACS  Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

## Reason for recall

Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2471-2020
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-05-22
- **Report date:** 2020-07-08

- **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-2471-2020

## Citation

> AI Analytics. FDA recall Z-2471-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2471-2020. Source: US FDA. Licensed CC0.

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