# FDA recall Z-0188-2024

> **Medtronic Navigation, Inc.** · Class I · device recall initiated 2023-09-27.

## 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.

## Distribution

Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV,  and WY.  O.U.S.(foreign) including countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNES, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIAN FEDERATION, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM

## Key facts

- **Recall number:** Z-0188-2024
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-27
- **Report date:** 2023-11-15

- **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-0188-2024

## Citation

> AI Analytics. FDA recall Z-0188-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0188-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*