# FDA recall Z-0383-2022

> **Medtronic Navigation, Inc.** · Class I · device recall initiated 2021-11-11.

## Product

Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software.     Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585

## Reason for recall

Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.

## Distribution

US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL, MS, MO, TX, MI, MT, OH, NY, VA, MA, CT, TN, WV, WA, NC, CO, NV, ME, LA, DE, NM, IN, UT, DC, OR, SC, OK, IA, HI, ID, KS, WY, MN, PR  OUS: AU, BN, GU, JP, KR, MY, NZ, SG, TH, VN, MM, CA, CZ, RU, AL, CY, DE, ES, FR, GB, HU, IL, IT, NL, PL, RO, CN, HK, TW, IN, LK, NP, AR, BB, BR, CL, CO, CR, DO, EC, MX, PE, PR, VE, NI, UY, AE, BH, DZ, EG, IQ, JO, KZ, KE, SA, LB, LY, MA, NA, PK, QA, ZA, TR, AT, BE, CH, DK, FI, GF, GR, IE, LV, LT, LU, PT, SE, SK, UK, BA, BG, CI, HR, RS, SI

## Key facts

- **Recall number:** Z-0383-2022
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-11
- **Report date:** 2021-12-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0383-2022

## Citation

> AI Analytics. FDA recall Z-0383-2022. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0383-2022. Source: US FDA. Licensed CC0.

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