International safety notice
During a performance test of our product, incorrect color correction data was programmed into the video scope's CCD image sensor. It turns out that there is. We have decided to recall the product.
Japan / PMDA Recalls · JPN · Sep 26, 2024
Key facts
| Title | During a performance test of our product, incorrect color correction data was programmed into the video scope's CCD image sensor. It turns out that there is. We have decided to recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) ビデオ flexible gastroduodenoscope (2) ビデオ flexible enteroscope Brand name: (1) EVIS EXERA III Upper gastrointestinal general purpose videoscope OLYMPUS GIF-H190N (2) EVIS EXERA III Small intestine videoscope OLYMPUS SIF-H190 |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | 2404347, 2404284, 2404366, 2404333, 2400801, 2404296, 2404330, 2800626, 2400772, 2404461, 2404242, 2404471 and 64 more |
| Date | Sep 26, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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