International safety notice
When using this device, we have confirmed that there are some cases where the tip of the endoscope cannot be properly attached. In the event of an accident, the equipment would need to be replaced and the procedure could be delayed, so we decided to recall the affected product. Did.
Japan / PMDA Recalls · JPN · Feb 19, 2024
Key facts
| Title | When using this device, we have confirmed that there are some cases where the tip of the endoscope cannot be properly attached. In the event of an accident, the equipment would need to be replaced and the procedure could be delayed, so we decided to recall the affected product. Did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) ビデオ flexible duodenoscope, (2) flexible duodenoscope Brand name: (1) EVIS LUCERA duodenal videoscope OLYMPUS JF TYPE 260V, EVIS duodenal videoscope OLYMPUS JF TYPE 240, EVIS duodenal videoscope OLYMPUS JF TYPE 140R (2) OES duodenal fiberscope OLYMPUS JF TYPE 1T40, duodenal fiberscope OLYMPUS JF TYPE TE3 |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | MAJ-411 |
| Date | Feb 19, 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