International safety notice
This product is part of the Inspired Flow product line and is distributed independently. We received a report from a medical institution regarding a malfunction in the power supply of the product, and upon investigation, we found that the circuit was overheating. If the adhesion between the connector that fixes the pin of the wire connection part and the cover is insufficient, power failure may occur in rare cases. It turns out. After investigating the manufacturing process of the manufacturer, we have confirmed that the adhesion is insufficient in products manufactured at a certain time. Therefore, we have decided to carry out a voluntary recall of the lot concerned.
Japan / PMDA Recalls · JPN · Apr 7, 2021
Key facts
| Title | This product is part of the Inspired Flow product line and is distributed independently. We received a report from a medical institution regarding a malfunction in the power supply of the product, and upon investigation, we found that the circuit was overheating. If the adhesion between the connector that fixes the pin of the wire connection part and the cover is insufficient, power failure may occur in rare cases. It turns out. After investigating the manufacturing process of the manufacturer, we have confirmed that the adhesion is insufficient in products manufactured at a certain time. Therefore, we have decided to carry out a voluntary recall of the lot concerned. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Heated humidifier Sales name: Inspired Flow |
| Manufacturer | Inspired Medical Japan Co., Ltd. |
| Models | 190237, 51007904, 202673, 51007903, 203773, 195240, 192306, 200103, 51007799, 51006765, 51007798, 200102 and 6 more |
| Date | Apr 7, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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