International safety notice
As a result of an investigation at the overseas manufacturer, it was determined that the following events may occur due to electrical defects in a specific lot of the product in question. It has been confirmed that there is a possibility that ・Noise occurs in the NIM system ・Lead-off (electrical connection broken) or high impedance state -Loss of neuromonitoring or intermittent neuromonitoring
Japan / PMDA Recalls · JPN · Nov 15, 2023
Key facts
| Title | As a result of an investigation at the overseas manufacturer, it was determined that the following events may occur due to electrical defects in a specific lot of the product in question. It has been confirmed that there is a possibility that ・Noise occurs in the NIM system ・Lead-off (electrical connection broken) or high impedance state -Loss of neuromonitoring or intermittent neuromonitoring |
|---|---|
| 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 | 0226130051, 0226166004, 0225994034, 0226030100, 0225798573, 0226337996, 0226150740, 0225785422, 0225784380, 8229708, 0225952300, 0225809609 and 16 more |
| Date | Nov 15, 2023 |
| 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