Vivo 45LS Ventilator- intended to provide continuous or intermittent… — Class II medical device recall Z-1382-2022
Ongoing recall by Breas Medical, Inc., reported 2022-07-20, distributed nationwide. A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AN
| Recall number | Z-1382-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breas Medical, Inc., North Billerica, MA, United States |
| Recall initiated | 2022-06-02 |
| Classified | 2022-07-13 |
| Reported by FDA | 2022-07-20 |
| Distributed | Nationwide (US) |
| Quantity | 1,113 units |
| UPC / GTIN / UDI-DI | 07321822300004 |
| Model numbers | 230000 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1382-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.