BEUDAMED
    FDA Recall Terminated

    ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800

    Recall: Z-0802-2019 · Initiated December 19, 2018

    Recall

    Recall Number
    Z-0802-2019
    Event Number
    81872
    Firm
    Arjohuntleigh Magog 2001 Rue Tanguay Magog Canada Quebec
    FEI Number
    3002655016
    Product Code
    IKZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 19, 2018
    Posted
    February 5, 2019
    Terminated
    January 26, 2022

    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.

    Action

    Arjo hand-delivered the notice with each RotoProne Therapy System rental and delivery beginning on 12/19/2018. Arjo will require the customer to confirm the notification has been received and understood via the signed delivery notification.

    Distribution

    US, Saudi Arabia, and Kuwait

    Quantity

    231 units