International safety notice
While checking the device (demonstration device), some screws came off. Since the possibility of the screw coming off due to lack of strength cannot be ruled out, we will take precautions against lots where a similar phenomenon may occur. We decided to carry out the main collection.
Japan / PMDA Recalls · JPN · May 23, 2023
Key facts
| Title | While checking the device (demonstration device), some screws came off. Since the possibility of the screw coming off due to lack of strength cannot be ruled out, we will take precautions against lots where a similar phenomenon may occur. We decided to carry out the main collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: forehead lantern Sales name: Wearable surgical lighting OPELAIII |
| Manufacturer | Taiyo Shoji Co., Ltd. |
| Models | H0245JP, H0302JP, H0332JP, H0277JP, H0228GL, H0268US, H0230US, H0268JP, H0267US, H0230JP, H0421US, H0238JP and 156 more |
| Date | May 23, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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