Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care — Class II medical device recall Z-2094-2015
Terminated recall by Breas Medical AB, reported 2015-07-22, distributed nationwide. Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneo
| Recall number | Z-2094-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breas Medical AB, Molnlycke, N/A, Sweden |
| Recall initiated | 2014-11-07 |
| Classified | 2015-07-16 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BE, CH, CL, CY, DE, DK, EC, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KW, LB, MY, NL, NO, PA, PL, PT, RS, RU, SA, SE, SG, SI, TH, TR |
| Quantity | 846 us |
| Reason classes | device malfunction |
Product
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
Reason for recall
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
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-2094-2015. 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.