FDA Device recall Z-1776-2024
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only
- FDA Device
- Class I
- ongoing
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class I recall of Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only by Medtronic Navigation, citing due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1776-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-03-26 |
| Published | 2024-05-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
Reason
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Identifiers
| code_info | UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Medtronic Navigation
- Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Re…
FDA Device · Class II · 2025-02-05 · Medtronic Navigation - StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intende…
FDA Device · Class II · 2024-10-16 · Medtronic Navigation - Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation - Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
FDA Device · Class II · 2024-01-17 · Medtronic Navigation - StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is inte…
FDA Device · Class I · 2023-11-15 · Medtronic Navigation
All Medtronic Navigation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1776-2024%22
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