International safety notice
When charging the product, the LED blinks red, which is an error message indicating that the battery level is low, and the battery is not charging. I received a report that it is not. As it has been discovered that this may cause a conduction failure and make charging impossible, a voluntary recall has been implemented. It was made.
Japan / PMDA Recalls · JPN · Nov 17, 2022
Key facts
| Title | When charging the product, the LED blinks red, which is an error message indicating that the battery level is low, and the battery is not charging. I received a report that it is not. As it has been discovered that this may cause a conduction failure and make charging impossible, a voluntary recall has been implemented. It was made. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: telemetry electroencephalograph Brand name: Patch type electroencephalogram HARU-2 |
| Manufacturer | PGV Co., Ltd. |
| Models | 2203020, 2203017, 2203016, 2205011, 2203007, 2203030, 2203019, 2203021, 2205017, 2203026, 2203018, 2203023 and 25 more |
| Date | Nov 17, 2022 |
| 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