International safety notice
At an overseas manufacturer, when using this device in HFO mode, the breathing circuit disconnection alarm occurs even though the breathing circuit is not disconnected. It has been confirmed that this occurs. To do. We would like to inform you that.
Japan / PMDA Recalls · JPN · Jul 3, 2024
Key facts
| Title | At an overseas manufacturer, when using this device in HFO mode, the breathing circuit disconnection alarm occurs even though the breathing circuit is not disconnected. It has been confirmed that this occurs. To do. We would like to inform you that. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neonatal/pediatric ventilator Sales name: Fabian HFO series |
| Manufacturer | Air Water Medical Co., Ltd. |
| Models | AH18HC-00851, AH18IC-00874, AH18HC-00849, AH18LD-01410, AH18HC-00855, AH18FC-00789, AH18LC-00959, AI-02004, AH18GC-00818, AH18LC-00960, AH18GC-00817, AI-02478 and 50 more |
| Date | Jul 3, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1