StealthStation S8 App versions 1 — Class II medical device recall Z-0050-2025
Ongoing recall by Medtronic Navigation, Inc., reported 2024-10-16, distributed nationwide. Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientati
| Recall number | Z-0050-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Lafayette, CO, United States |
| Recall initiated | 2024-08-22 |
| Classified | 2024-10-10 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, DE, DK, EG, ES, FI, FR, GB, GR, HR, HU, IL, IN, IS, IT, JO, JP, KE, KR, LB, LT, MA, MX, MY, NI, NL, OM, PA, PH, PK, PL, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, ZA |
| Quantity | 1,801 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000368494, 00763000456986 |
| Serial numbers | 420002290, N06805776, N07323682, N07323683, N07323687, N07326235, N07334454, N07334475, N07338479, N07338480, N07338482, N07338929, N07354639, N07354642, N07354643, N07354644, N07354645, N07355155, N07357492, N07357493, N07360505, N07360506, N07362322, N07362323, N07364218 and 475 more |
| Model numbers | 9735762 |
Product
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
Reason for recall
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
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-0050-2025. 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.