BEUDAMED
    FDA Enforcement Class II Terminated

    ROSA One 3.1 Brain Application

    Recall: Z-1151-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1151-2020
    Event ID
    84642
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDTECH SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    January 6, 2020
    Classification Date
    February 11, 2020
    Termination Date
    November 5, 2020
    Address
    900 Rue Du Mas De Verchant, Montpellier, N/A, France

    Description

    ROSA One 3.1 Brain Application

    Reason

    Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.

    Code Info

    Serial Number / UDI Number: 1) BS19037 / UDI - (01)03760244030948(11)190423(21)BS19037; 2) BS19038 / UDI - (01)03760244030948(11)190415(21)BS19038; 3) BS19039 / UDI - (01)03760244030948(11)190430(21)BS19039; 4) BS19040 / UDI - (01)03760244030948(11)190513(21)BS19040; 5) BS19041 / UDI - (01)03760244030948(11)190523(21)BS19041; 6) BS19043 / UDI - (01)03760244030948(11)190513(21)BS19043; 7) BS19049 / UDI - (01)03760244032492(11)190730(21)BS19049; 8) BS19050 / UDI - (01)03760244032492(11)190726(21)BS19050; 9) BS19052 / UDI - (01)03760244032492(11)190731(21)BS19052; 10) BS19054 / UDI - (01)03760244032492(11)190912(21)BS19054; 11) BS19057 / UDI - (01)03760244032492(11)191003(21)BS19057; 12) BS19058 / UDI - (01)03760244032492(11)191011(21)BS19058.

    Distribution

    US Nationwide

    Quantity

    39 units