International safety notice
In version 2.0 or 2.0.1 of the target product's software "Stealthstation S8 Application", Under certain conditions during surgical (including DBS and stereotactic neurosurgery) or ENT procedures, surgical planning data may It turns out that there is a risk of shifting to a position that is not present. plug. We will implement it.
Japan / PMDA Recalls · JPN · Feb 19, 2024
Key facts
| Title | In version 2.0 or 2.0.1 of the target product's software "Stealthstation S8 Application", Under certain conditions during surgical (including DBS and stereotactic neurosurgery) or ENT procedures, surgical planning data may It turns out that there is a risk of shifting to a position that is not present. plug. We will implement it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Neurosurgical navigation unit Sales name: (1) Stealth Station S8 (2) Stealth Station Flex ENT |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 9735736, 9735919, 0011513686, 0011603943, 0011443289, 9735920, 0011415784, 0011629337, 0011450832, 0011513758, 0011734779, 0011440624 and 78 more |
| Date | Feb 19, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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