BEUDAMED
    FDA Enforcement Class I Ongoing

    Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

    Recall: Z-1776-2024 · Reported May 15, 2024

    Enforcement

    Recall Number
    Z-1776-2024
    Event ID
    94411
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 15, 2024
    Initiation Date
    March 26, 2024
    Classification Date
    May 9, 2024
    Address
    200 Medtronic Drive, N/A, Lafayette, CO, 80026, United States

    Description

    Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

    Reason

    Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

    Code Info

    UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Republic Of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    3286 applications.