Protective Cover Vivo 55/65 — Class II medical device recall Z-1352-2020
Terminated recall by Breas Medical, Inc., reported 2020-03-04, distributed nationwide. The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the p
| Recall number | Z-1352-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breas Medical, Inc., North Billerica, MA, United States |
| Recall initiated | 2020-01-28 |
| Classified | 2020-02-24 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2020-09-15 |
| Distributed | Nationwide (US) |
| Quantity | 629 |
| Model numbers | 006344 |
Product
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.
Reason for recall
The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
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-1352-2020. 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.