# FDA recall Z-3128-2017

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2015-03-09.

## Product

Fujifilm Endoscope   Model ED-530XT      Product Usage:  This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

## Reason for recall

Fujifilm is reporting a corrective action due to an FDA inspection.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-3128-2017
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-03-09
- **Report date:** 2017-09-20
- **Termination date:** 2018-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3128-2017

## Citation

> AI Analytics. FDA recall Z-3128-2017. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-3128-2017. Source: US FDA. Licensed CC0.

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