Z-0383-2022Class I

Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy...

Name: Z-0383-2022 Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy...
Creator: Medtronic Navigation, Inc.
Published: 2021-11-11
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2021-11-11 / Open, Classified / root cause: software

FDA source

Medtronic Navigation, Inc. began a recall of Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation... on 2021-11-11. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0383-2022
Classification: Class I
Status: Open, Classified
Initiated: 2021-11-11
Posted: 2021-12-22
Recalling firm: Medtronic Navigation, Inc
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
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: software
FDA root cause: Software design
Action: On 11/11/21, correction notices were distributed to healthcare professionals. The recalling firm will provide a warning and instructional placard to be applied to impacted systems. Customers with questions are encouraged to call Technical Services for help at: 1-888-826-5603. Customers are asked to complete and return the confirmation form and maintain a copy of this correction notice. Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring: Firm recommends NOT turning off Guidance View after locking the biopsy trajectory in the Cranial software. After locking trajectory for biopsy needle navigation, always ensure Guidance View remains an active view in at least one screen layout quadrant. If a discrepancy is detected between the biopsy depth gauge graphic and the other 2D information: 1) Obstruct the camera field of view of the biopsy needle or reference frame to cause red status. 2) Return to green status by no longer obstructing camera field of view of the biopsy needle and reference frame. 3) Use the Cycle Views icon to refresh guidance view and confirm that the biopsy depth gauge graphic matches the distance to target values and the position to target information provided by the 2D crosshairs. 4) Visually confirm accuracy before proceeding with navigation. Always Visually confirm navigational accuracy and confirm that the biopsy depth gauge graphic matches the distance to target values and matches the position to target information provided by the 2D crosshairs, which represent the tip position of the navigated instrument. Use the Biopsy Needle Mechanical Depth Stop. If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system.
Quantity in commerce: 2587
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
Product codes and lots: 9733763, Version: 2.2.8; 9735585, Versions: 3.1.1, 3.1.2, 3.1.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0383-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0383-2022	Class I	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-22

Product code HAW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)