International safety notice
The multi-function pedal, which is a component of this product, allows you to press the foot switch to The magnetic force of the magnet acts on the sensor, which controls the rotation of the motor. The manufacturer has recently announced that the magnet inside the foot switch may have shifted or come off in certain batches. We have confirmed that there is a risk of an event occurring such as a slow start or the motor not being able to stop, so we have decided to voluntarily recall the product. did.
Japan / PMDA Recalls · JPN · May 12, 2021
Key facts
| Title | The multi-function pedal, which is a component of this product, allows you to press the foot switch to The magnetic force of the magnet acts on the sensor, which controls the rotation of the motor. The manufacturer has recently announced that the magnet inside the foot switch may have shifted or come off in certain batches. We have confirmed that there is a risk of an event occurring such as a slow start or the motor not being able to stop, so we have decided to voluntarily recall the product. did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Electric bone surgery instrument Sales name: OSSEODUO shaver & drill system |
| Manufacturer | Bien Air Asia Co., Ltd. |
| Models | 19B0057, 1600517-001, 16B0005, 18E0024, 17I0029, 18A0008, 16B0030, 16B0001, 17J0026, 19E0020, 17B0024, 17B0026 and 47 more |
| Date | May 12, 2021 |
| 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