International safety notice
The manufacturer has stated that water was supplied to the automatic water supply type humidification chamber from the gas port, and the main body of the device was exposed to water, causing water to seep inside. Cases have been reported overseas where water was found. Although it satisfies the specifications (dustproof and waterproof protection class IP21), in the event of an unforeseen situation such as the one mentioned above, there is a risk of water leakage inside the device. In order to minimize the impact of water on parts, we have made improvements to increase waterproofness, so we have implemented a voluntary recall of conventional products and made improvements. I decided to exchange the product.
Japan / PMDA Recalls · JPN · May 10, 2021
Key facts
| Title | The manufacturer has stated that water was supplied to the automatic water supply type humidification chamber from the gas port, and the main body of the device was exposed to water, causing water to seep inside. Cases have been reported overseas where water was found. Although it satisfies the specifications (dustproof and waterproof protection class IP21), in the event of an unforeseen situation such as the one mentioned above, there is a risk of water leakage inside the device. In order to minimize the impact of water on parts, we have made improvements to increase waterproofness, so we have implemented a voluntary recall of conventional products and made improvements. I decided to exchange the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Heated humidifier Sales name: Inspired Flow |
| Manufacturer | Inspired Medical Japan Co., Ltd. |
| Models | 1852040075, 2019030002, 2019030028, 1852040095, 2011040018, 2019030094, 1852040004, 1852040070, 1852040110, 2019030007, 1852040127, 2011040043 and 182 more |
| Date | May 10, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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