International safety notice
As a result of durability tests on the product, the resistance value of some of the electrode materials of the pads worn on the skin in certain lots was found to be It has been confirmed that it is on the rise. We are implementing a voluntary recall as it has become clear that there is a possibility that a proper energization effect may not be obtained.
Japan / PMDA Recalls · JPN · May 29, 2024
Key facts
| Title | As a result of durability tests on the product, the resistance value of some of the electrode materials of the pads worn on the skin in certain lots was found to be It has been confirmed that it is on the rise. We are implementing a voluntary recall as it has become clear that there is a possibility that a proper energization effect may not be obtained. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Moving electrode for removing fine particles on body surface Brand name: Defibrillation disposable pad Dynapad TEB |
| Manufacturer | Fukuda Electronics Co., Ltd. |
| Models | TEB-300DR, 1240137463, 1240137462, 1240109168, TEB-300DRS, 1240185787, 1240169250 |
| Date | May 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