International safety notice
This product is intended to provide an audible alarm to the user under certain conditions. If this product was manufactured before August 14, 2017, the speaker may cause an alarm. It has been confirmed that the sound is distorted, becomes intermittent, or the volume becomes inaudible. It has been done. has passed its useful life (5 years), but the target product shipped to the market in Japan also Due to the possibility that some items may remain, we will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Apr 8, 2024
Key facts
| Title | This product is intended to provide an audible alarm to the user under certain conditions. If this product was manufactured before August 14, 2017, the speaker may cause an alarm. It has been confirmed that the sound is distorted, becomes intermittent, or the volume becomes inaudible. It has been done. has passed its useful life (5 years), but the target product shipped to the market in Japan also Due to the possibility that some items may remain, we will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Heated humidifier Sales name: (1) Flow generator Airvo (2) Flow generator myAirvo |
| Manufacturer | Fisher & Paykel Healthcare Co., Ltd. |
| Models | 161109039291, 170209044941, 160316025850, 150810018740, 160225025327, 150309012088, 160218024852, 160316025849, 150414013212, 150824019336, 170223045835, 150803018521 and 2105 more |
| Date | Apr 8, 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