—#203577

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K212397
Affected lot / code info: 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.

Why it was recalled

Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.

Root cause (FDA determination)

Software design

Action the firm took

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 rs.navtechsupport@medtronic.com 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 neuro.quality@medtronic.com. 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.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 200 Medtronic Drive, Lafayette, Colorado 80026

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2023-09-27
Posted by FDA: 2023-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203577. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.