International safety notice
After receiving a report of a problem with the angle function from a domestic medical institution, we investigated and found that this event occurred due to an error in the repair work. Since we have confirmed that this is a possibility, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Jul 8, 2022
Key facts
| Title | After receiving a report of a problem with the angle function from a domestic medical institution, we investigated and found that this event occurred due to an error in the repair work. Since we have confirmed that this is a possibility, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: ビデオflexible gastroduodenoscope Sales name: Pentax Video Upper Gastrointestinal Scope EG16-K10 |
| Manufacturer | HOYA Co., Ltd. |
| Models | A110214, A110415, A110032, EG16-K10, A110410, A110293, A110159, A110222, B130019, A110299, A110416, B130010 and 1 more |
| Date | Jul 8, 2022 |
| 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