International safety notice
When importing measurement data from an ultrasound diagnostic device with the program medical device, if conditions overlap, data from another patient may be It has been found that there is a possibility that the data may be mixed with the measured data of. For this reason, we will replace the entire medical device program that corrected the defect and reinstall it as a recall. I will do it.
Japan / PMDA Recalls · JPN · Jun 8, 2023
Key facts
| Title | When importing measurement data from an ultrasound diagnostic device with the program medical device, if conditions overlap, data from another patient may be It has been found that there is a possibility that the data may be mixed with the measured data of . For this reason, we will replace the entire medical device program that corrected the defect and reinstall it as a recall. I will do it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Program for ultrasound machine workstations Sales name: Ultrasound image analysis program UltraExtend NX CUW-U001S |
| Manufacturer | Canon Medical Systems Inc. |
| Models | 99A2292006, CUW-U001S, 99A22Z2010, 99A2222001, 99A2222005, 99A2292007 |
| Date | Jun 8, 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