Z-0188-2024Class I

StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with...

Name: Z-0188-2024 StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with...
Creator: Medtronic Navigation, Inc.
Published: 2023-09-27
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2023-09-27 / Open, Classified / root cause: software

FDA source

Medtronic Navigation, Inc. began a recall of 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... on 2023-09-27. FDA classified it as Class I and gives the reason as "Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location". 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-0188-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-09-27
Posted: 2023-11-10
Recalling firm: Medtronic Navigation, Inc
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
Root cause tag: software
FDA root cause: Software design
Action: On 09/27/2023, the firm sent an "URGENT: MEDICAL DEVICE CORRETION" Letter/Communication via UPS to customer informing them of a software anomaly affecting certain StealthStation S8 and StealthStation FlexENT system with the StealthStation S8 App software version 2.0 and 2.0.1. Due to the software anomaly, there is the potential for the surgical planning data to encounter a displayed shift which could result in proceeding to an incorrect location from the planned target. This result in unintended tissue damage leading to permanent neurological injury, additional pass of device (biopsy needle or electrode), prolonged procedure or need for additional surgery. Customer are instructed to: 1. Follow the below instructions and refer to Appendix A for full details on impacted systems, issues and mitigations: a. Do not change the reference exam in Cranial or ENT procedures, if the surgical planning data is defined on a reference exam merged with pre-merge type or diffusion series. 2. Please review this information, including the additional details in Appendix A, with all physician users. If you have any questions related to this issue, please contact Medtronic Technical Services for help at 1-888-826-5603 or email at [email protected] 3. Please confirm via the enclosed confirmation form that this notification has been communicated within your facility with all physician users. Send the completed Customer Confirmation Form to Medtronic via email at [email protected]. a. Medtronic will contact your facility to coordinate the software update when it is available. 4. This notice needs to be passed on to those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. Questions or assistance, contact Medtronic Sales Representatives or Technical Services at 1-888-826-5603.
Quantity in commerce: 5,240 affected systems
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
Product codes and lots: Model Number: 9735762 UDI-DI Code: 00763000532123 Software Versions 2.0 and 2.0.1 All systems with the impacted software version regardless of how it was purchased Updated list of Product Models/Serial provide on 06/06/2024 and was uploaded to Associated Documents.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0188-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0188-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-09

Product code HAW

K212397Class IIStealthStation S8 Cranial v2.0Medtronic Navigation / cleared 2021-12-22

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)