International safety notice
There was one report that white smoke was generated when this device was left on a desk after it was fully charged. It was discovered that the lithium-ion battery was burned out due to an internal short circuit. Although we have confirmed that there is no such event, we cannot deny the risk of this happening, so we are implementing a voluntary recall.
Japan / PMDA Recalls · JPN · Feb 15, 2024
Key facts
| Title | There was one report that white smoke was generated when this device was left on a desk after it was fully charged. It was discovered that the lithium-ion battery was burned out due to an internal short circuit. Although we have confirmed that there is no such event, we cannot deny the risk of this happening, so we are implementing a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pulse oximeter Sales name: AnyPal ATP-03 |
| Manufacturer | Fukuda Electronics Co., Ltd. |
| Models | 50000001, 50017410 |
| Date | Feb 15, 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