International safety notice
As part of its internal complaint investigation, foreign manufacturer ResMed Pty Ltd revealed that deteriorated electrical components inside the product were When operating on battery only, the total power loss alarm duration is less than the specified 2 minutes or never occurs. We have identified an issue that may cause the function to not activate properly.
Japan / PMDA Recalls · JPN · Nov 9, 2023
Key facts
| Title | As part of its internal complaint investigation, foreign manufacturer ResMed Pty Ltd revealed that deteriorated electrical components inside the product were When operating on battery only, the total power loss alarm duration is less than the specified 2 minutes or never occurs. We have identified an issue that may cause the function to not activate properly. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Artificial respirator for adults Brand name: Clean Air ASTRAL |
| Manufacturer | ResMed Co., Ltd. |
| Models | 22182024039, 22161553419, 22191510307, 22211792608, 22191510373, 22211764328, 22181698992, 22181331652, 22211764366, 22161553431, 22181699000, 22211764395 and 71 more |
| Date | Nov 9, 2023 |
| 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