International safety notice
Two incidents have been reported overseas where the product disintegrated after use. Since we cannot deny the possibility that similar events may occur with other products, we have decided to implement a voluntary recall. Ta.
Japan / PMDA Recalls · JPN · Mar 10, 2023
Key facts
| Title | Two incidents have been reported overseas where the product disintegrated after use. Since we cannot deny the possibility that similar events may occur with other products, we have decided to implement a voluntary recall. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Ophthalmic cryosurgery unit Sales name: Cryotrek |
| Manufacturer | Beaver Visitec International Japan Co., Ltd. |
| Models | 20229034 |
| Date | Mar 10, 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