StealthStation Cranial Software — Class I medical device recall Z-1630-2023
Ongoing recall by Medtronic Navigation, Inc., reported 2023-06-14, distributed nationwide. During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic di
| Recall number | Z-1630-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Lafayette, CO, United States |
| Recall initiated | 2023-04-11 |
| Classified | 2023-06-02 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, CA, CH, CL, CZ, DK, ES, FR, GB, GR, HR, IE, IN, IT, JP, KR, LU, NZ, PL, PT, RO, SG, SK, TR, TW |
| Quantity | 746 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000631635, 00763000631765, 00763000631826 |
| Model numbers | 9735585, 9735586 |
Product
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Reason for recall
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury
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-1630-2023. 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.