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U.S. Department of Health and Human Services

Class 1 Device Recall StealthStation S8 App Version 2.0 and 2.0.1

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  Class 1 Device Recall StealthStation S8 App Version 2.0 and 2.0.1 see related information
Date Initiated by Firm September 27, 2023
Date Posted November 10, 2023
Recall Status1 Open3, Classified
Recall Number Z-0188-2024
Recall Event ID 93158
510(K)Number K212397  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
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.
Code Information 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
Recalling Firm/
Manufacturer
Medtronic Navigation, Inc.
200 Medtronic Drive
Lafayette CO 80026
For Additional Information Contact Christine Stewart
720-890-3200
Manufacturer Reason
for Recall
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
FDA Determined
Cause 2
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 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.
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = Medtronic Navigation
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