International safety notice
At an overseas manufacturer, two lot numbers of the affected product were found to be defective during functional endoscopic sinus surgery (FESS). The possibility of this occurring has been confirmed. When registering an instrument, you may receive an error message indicating that the registration failed. vinegar.
Japan / PMDA Recalls · JPN · Dec 19, 2022
Key facts
| Title | At an overseas manufacturer, two lot numbers of the affected product were found to be defective during functional endoscopic sinus surgery (FESS). The possibility of this occurring has been confirmed. When registering an instrument, you may receive an error message indicating that the registration failed. vinegar. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neurosurgical navigation unit Sales name: Stealth Station S8 |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 9734887XOM |
| Date | Dec 19, 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