StealthStation S8 Application version 2 — Class I medical device recall Z-0188-2024
Ongoing recall by Medtronic Navigation, Inc., reported 2023-11-15, distributed nationwide. Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintend
| Recall number | Z-0188-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Lafayette, CO, United States |
| Recall initiated | 2023-09-27 |
| Classified | 2023-11-09 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CO, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JP, KE, KR, KW, LT, LU, LV, MX, MY, NL, NO, NZ, PA, PH, PL, PT, RO, RS, SE, SG, SI, SK, TH, TR, TW, UA, ZA |
| Quantity | 5,240 affected |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000532123 |
| Model numbers | 9735762 |
Product
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
Reason for recall
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0188-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.