# FDA recall Z-1492-2021

> **Boston Scientific Corporation** · Class III · device recall initiated 2021-03-16.

## Product

EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN:  M00542430

## Reason for recall

May have been programmed with a less than optimal brightness setting resulting in a darker than  desired image

## Distribution

US Nationwide distribution in the states of CA, FL, NJ.

## Key facts

- **Recall number:** Z-1492-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-16
- **Report date:** 2021-05-05
- **Termination date:** 2022-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1492-2021

## Citation

> AI Analytics. FDA recall Z-1492-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1492-2021. Source: US FDA. Licensed CC0.

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