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Vapotherm
VAPOTHERM, INC. · Model PF-OAM-MAS · UDI-DI 00841737103448
3
510(k) clearances
39
Adverse events (3 deaths)
1
Recalls
6
Facilities
Description
Precision Flow Oxygen Assist Module, Massimo
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-07 | Fisher & Paykel Healthcare, Ltd. | Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happe |
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