International safety notice
It was confirmed that the stickers were pasted as "right" and "right" on the electrode part of this product instead of the "right" and "left" stickers. Due to this, we are conducting a voluntary recall.
Japan / PMDA Recalls · JPN · Feb 29, 2024
Key facts
| Title | It was confirmed that the stickers were pasted as "right" and "right" on the electrode part of this product instead of the "right" and "left" stickers. Due to this, we are conducting a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: scalp electroencephalogram electrode Brand name: Insomnograph adult electrode |
| Manufacturer | Teikoku Tsushin Kogyo Co., Ltd. |
| Models | 4158032-0, 4158042-0, 4158072-0, 4158082-0, 4169622-0, 4172822-0, 4169632-0, 4169372-0, 4169382-0, 4158062-0, 4158052-0, 4172832-0 |
| Date | Feb 29, 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