BEUDAMED
    FDA Enforcement Class II Terminated

    ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

    Recall: Z-0802-2019 · Reported February 13, 2019

    Enforcement

    Recall Number
    Z-0802-2019
    Event ID
    81872
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arjohuntleigh Magog
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    February 13, 2019
    Initiation Date
    December 19, 2018
    Classification Date
    February 5, 2019
    Termination Date
    January 26, 2022
    Address
    2001 Rue Tanguay, Magog, Quebec, N/A, Canada

    Description

    ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

    Reason

    Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.

    Code Info

    All Serial Numbers

    Distribution

    US, Saudi Arabia, and Kuwait

    Quantity

    231 units