BEUDAMED
    FDA Recall Open, Classified

    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

    Recall: Z-1630-2023 · Initiated April 11, 2023

    Recall

    Recall Number
    Z-1630-2023
    Event Number
    92141
    Firm
    Medtronic Navigation, Inc.
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 11, 2023
    Posted
    June 2, 2023
    Address
    200 Medtronic Drive, Lafayette, CO, 80026

    Description

    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

    Reason

    During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury

    Action

    On 4/11/23, correction notices were sent to healthcare professionals that were advised of the following; 1) Do not utilize the following: a) Biopsy Depth Gauge Graphic in Cranial Biopsy procedures. In accordance with the IFU: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient. Always use the Biopsy Needle Mechanical Depth Stop. If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system. b) Distance to/past Target value for Tumor Resection, Shunt Placement, and DBS procedures. Per the IFU: "Warning: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient." and "If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system." 2) All physician users should review the correction notice. Pass on the notice to all 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. 3) Complete and return the customer confirmation form that can be returned to [email protected]. Firm will provide warning and instructional placards to be applied to the affected systems. Firm is currently working on a software update and will communicate additional information when it becomes available. If you have any questions related to this issue, contact Technical Services for help at: 1-888-826-5603 or email at [email protected]

    Distribution

    Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY. OUS (foreign): ALBANIA, ARGENTINA, Australia, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, Bosnia and Herzegovina, BULGARIA, CANADA, CHILE, CROATIA, CZECH REPUBLIC, DENMARK, FRANCE, GREECE, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MARTINIQUE, NEW ZEALAND, POLAND, PORTUGAL, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, Turkey, UNITED ARAB EMIRATES, UNITED KINGDOM

    Quantity

    746