BEUDAMED
    FDA Enforcement Class II Terminated

    StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

    Recall: Z-2707-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2707-2020
    Event ID
    85901
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 5, 2020
    Initiation Date
    June 5, 2020
    Classification Date
    July 27, 2020
    Termination Date
    May 28, 2024
    Address
    826 Coal Creek Cir, N/A, Louisville, CO, 80027-9710, United States

    Description

    StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

    Reason

    There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.

    Code Info

    StealthStation S7 Serial Number N06164844 with Polaris Spectra Camera Serial Number P7-01896; and StealthStation S7 Serial Number N07308697 with Polaris Spectra Camera Serial Number P7-18852.

    Distribution

    US Nationwide distribution including in the states of Alabama and Massachusetts.

    Quantity

    2