StealthStation Cranial Software — Class I medical device recall Z-1666-2023

Ongoing recall by Medtronic Navigation, Inc., reported 2023-06-14, distributed in PR. In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Nav

Recall number	`Z-1666-2023`
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	PR
Countries outside the US	AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CO, CZ, DE, DK, DO, EC, ES, FI, FR, GR, HR, HU, IE, IL, IN, IT, JP, KE, KR, LK, LV, MX, NL, PK, PL, PT, RO, SA, SE, SG, SI, TH, TR, ZA
Quantity	556
Reason classes	software
UPC / GTIN / UDI-DI	`00763000253165`, `00763000299927`, `00763000299972`, `00763000306762`, `00763000517267`, `00763000517274`, `00763000517335`
Model numbers	`9735585`

Product

StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems

Reason for recall

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

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-1666-2023. 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.