# FDA recall Z-1382-2022

> **Breas Medical, Inc.** · Class II · device recall initiated 2022-06-02.

## Product

Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation    Model Number: 230000     ¿	If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

## Reason for recall

A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1382-2022
- **Recalling firm:** Breas Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-02
- **Report date:** 2022-07-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1382-2022

## Citation

> AI Analytics. FDA recall Z-1382-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1382-2022. Source: US FDA. Licensed CC0.

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