Class II — Breas Medical, Inc.
| Recalling firm | BREAS MEDICAL, INC. |
|---|---|
| Registered facility | BREAS MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| 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 |
| Quantity | 1,113 units |
| Distribution | Nationwide |
| Initiated | 2022-06-02 |
| Classified | 2022-07-13 |
| Recall number | Z-1382-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Breas Medical, Inc. (Z-1382-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90433/
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