Class II — Breas Medical AB
| Recalling firm | Breas Medical |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care |
| Quantity | 846 US |
| Distribution | Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom. |
| Initiated | 2014-11-07 |
| Classified | 2015-07-16 |
| Terminated | 2016-04-07 |
| Recall number | Z-2094-2015 |
| 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 AB (Z-2094-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69760/
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