International safety notice
Due to a bug in the medical device program, the distance measurement function and area measurement function are not displayed correctly on images other than mammogram images. It turns out that it is not shown. Therefore, as a recall, we will replace the entire medical device program that corrected the defect and reinstall it. I will.
Japan / PMDA Recalls · JPN · Sep 10, 2021
Key facts
| Title | Due to a bug in the medical device program, the distance measurement function and area measurement function are not displayed correctly on images other than mammogram images. It turns out that it is not shown. Therefore, as a recall, we will replace the entire medical device program that corrected the defect and reinstall it. I will. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Program for general-purpose diagnostic imaging equipment workstations Brand name: General-purpose image diagnostic workstation program RapideyeCore SVIW-TMH05 |
| Manufacturer | Canon Medical Systems Inc. |
| Models | 10B2072334, 10B2142425, 10B20Z2388, 10B2142415, 10B2142420, SVIW-TMH05, 10B2172469, 10B2142421, 10B20Y2372, 10B20Y2375, 10B2152435, 10B2152431 and 91 more |
| Date | Sep 10, 2021 |
| 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