# FDA recall Z-3225-2017

> **Fujifilm Medical Systems U.S.A., Inc.** · Class II · device recall initiated 2017-07-21.

## Product

FUJINON ED-530XT.    This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

## Reason for recall

An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device.    The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-3225-2017
- **Recalling firm:** Fujifilm Medical Systems U.S.A., Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-21
- **Report date:** 2017-10-04
- **Termination date:** 2018-07-12

- **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-3225-2017

## Citation

> AI Analytics. FDA recall Z-3225-2017. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-3225-2017. Source: US FDA. Licensed CC0.

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