# FDA recall Z-1666-2023

> **Medtronic Navigation, Inc.** · Class I · device recall initiated 2023-04-11.

## 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

## Distribution

US Distribution: PR.  OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVOIRE, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, LATVIA, MEXICO, MOLDAVIA, NETHERLANDS, PAKISTAN, POLAND, PORTUGAL, REPUBLIC of KOREA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES

## Key facts

- **Recall number:** Z-1666-2023
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-11
- **Report date:** 2023-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lafayette, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1666-2023

## Citation

> AI Analytics. FDA recall Z-1666-2023. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1666-2023. Source: US FDA. Licensed CC0.

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