International safety notice
As a result of an investigation at an overseas manufacturer, an electrode check was performed on a specific lot of products due to an electrical defect in the product. It has been confirmed that the test may fail, display error messages, and generate noise. We will carry out a voluntary recall of the product.
Japan / PMDA Recalls · JPN · Jan 11, 2022
Key facts
| Title | As a result of an investigation at an overseas manufacturer, an electrode check was performed on a specific lot of products due to an electrical defect in the product. It has been confirmed that the test may fail, display error messages, and generate noise. We will carry out a voluntary recall of the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Electromyography electrode (short-term use ventilation tracheal tube) Sales name: NIM TriVantage EMG tube |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 0220517619, 8229707, 0221710525, 0218762815, 0219010818, 0218762697, 0220087594, 0218762703, 0221146446, 0220087598, 0222495993, 0218452814 and 179 more |
| Date | Jan 11, 2022 |
| 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