Drug recall
Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
FDA recall event 69760 · Class II · Breas Medical AB
Key facts
| Event ID | 69760 |
|---|---|
| Recall numbers | Z-2094-2015 |
| Recalling firm | Breas Medical AB |
| Product type | Devices |
| Products | Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 7, 2014 |
| Report date | Jul 22, 2015 |
| Termination date | Apr 7, 2016 |
| City | Molnlycke |
| Country | Sweden |
| FEI number | 3003244771 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: