International safety notice
Target product software "StealthStation S8 Application" version 1.0.1, 1.0.2, 1.0.3, 1.1.0 and In 1.2.0, the "distance to target" or "tip stop" numbers, letters, It turns out that information about decimal points may be missing. We will collect the software and install the software with the defect fixed.
Japan / PMDA Recalls · JPN · Apr 19, 2024
Key facts
| Title | Target product software "StealthStation S8 Application" version 1.0.1, 1.0.2, 1.0.3, 1.1.0 and In 1.2.0, the "distance to target" or "tip stop" numbers, letters, It turns out that information about decimal points may be missing. We will collect the software and install the software with the defect fixed. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neurosurgical navigation unit Sales name: Stealth Station S8 |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 0010318080, 0009707722, 0010102297, 0009820303, 0010192610, 0010414057, 0010462480, 0010152460, 0011195633, 0009480723, 0009549859, 0009848176 and 157 more |
| Date | Apr 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