Facility
BREAS MEDICAL AB
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3003244771 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | FORETAGSVAGEN 1 MOLNLYCKE Vastra Gotaland, SE 43533 |
| Registration status | Active · expires 2026 |
| Parent company | Breas Medical (owner-operator 10046282) |
| Brand names | Vivo 3 |
Devices registered here (2)
- Sv70 VentilatorProduct code MNT · Class II · Anesthesiology · 21 CFR 868.5895
- Humidifier, Respiratory Gas, (Direct Patient Interface)Product code BTT · Class II · Anesthesiology · 21 CFR 868.5450
Recalls & enforcement
- Class IITerminated2014-11-07Unintended 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 f
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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