International safety notice
The noise suppression capacitor used in the control parts was damaged. Unusual behavior was observed. Normally, the movement is proportional to the shaking of the user's body, It was found that the damage caused the device to suddenly move rapidly regardless of the shaking of the body. The load on a capacitor for noise suppression varies depending on the installation environment of the equipment. Although this damage was judged to be a rare case, Due to the risk of the user falling due to malfunction, We have decided to recall all products.
Japan / PMDA Recalls · JPN · Feb 22, 2024
Key facts
| Title | The noise suppression capacitor used in the control parts was damaged. Unusual behavior was observed. Normally, the movement is proportional to the shaking of the user's body, It was found that the damage caused the device to suddenly move rapidly regardless of the shaking of the body. The load on a capacitor for noise suppression varies depending on the installation environment of the equipment. Although this damage was judged to be a rare case, Due to the risk of the user falling due to malfunction, We have decided to recall all products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balance function meter Sales name: BASYS |
| Manufacturer | Tech Gihan Co., Ltd. |
| Models | SMC10021Y056, SMB100184034, SMB100204047, 87037, SMB100172019, SMB10018102, SMB100181029, SMC100221057, SMB100196041, SMB100218054, SMB10005, SMB100178026 and 41 more |
| Date | Feb 22, 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