International safety notice
If you use it immediately after installing the battery, it will work normally, but if you use it again after a while, the power will not turn on and it will not work. It happened. As a result of our investigation, we found that there is a problem with the software of this product, which may cause it to stop working if a period of time elapses after the battery is installed. It has become clear that. For this reason, we have decided to implement a voluntary recall of the affected products in Japan.
Japan / PMDA Recalls · JPN · Mar 31, 2022
Key facts
| Title | If you use it immediately after installing the battery, it will work normally, but if you use it again after a while, the power will not turn on and it will not work. It happened. As a result of our investigation, we found that there is a problem with the software of this product, which may cause it to stop working if a period of time elapses after the battery is installed. It has become clear that. For this reason, we have decided to implement a voluntary recall of the affected products in Japan. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pulse oximeter Brand name: Pulse oximeter NE |
| Manufacturer | AS ONE Co., Ltd. |
| Models | 2107210, 7-828-01, 2107200, 7-828-02 |
| Date | Mar 31, 2022 |
| 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