FDA Device recall Z-1666-2023
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
- FDA Device
- Class I
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class I recall of StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems by Medtronic Navigation, citing in nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor res….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1666-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-04-11 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Navigation |
| Distribution | PR |
Product
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Reason
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury
Identifiers
| code_info | Model/UDI-DI/Software Versions: 9735585/00763000253165, 00763000306762 (inside Kits: 00763000299927, 00763000299972), 0…Model/UDI-DI/Software Versions: 9735585/00763000253165, 00763000306762 (inside Kits: 00763000299927, 00763000299972), 00763000517267(inside Kits: 00763000517274, 00763000517335)/v3.1.1, 3.1.2, and 3.1.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2024-01-17 · Medtronic Navigation - Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
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All Medtronic Navigation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1666-2023%22
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