# FDA recall Z-0943-2022

> **Breas Medical, Inc.** · Class II · device recall initiated 2022-03-21.

## Product

Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models  Article no 007384

## Reason for recall

Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0943-2022
- **Recalling firm:** Breas Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-21
- **Report date:** 2022-04-20
- **Termination date:** 2024-12-13

- **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-0943-2022

## Citation

> AI Analytics. FDA recall Z-0943-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0943-2022. Source: US FDA. Licensed CC0.

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