BEUDAMED
    FDA Recall Terminated

    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

    Recall: Z-1217-2015 · Initiated December 3, 2014

    Recall

    Recall Number
    Z-1217-2015
    Event Number
    69970
    Firm
    Arjo Hospital Equipment AB HANS MICHELSENSGATAN
    FEI Number
    3002806395
    Product Code
    IKZ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    December 3, 2014
    Posted
    February 27, 2015
    Terminated
    October 30, 2015
    Address
    10 Malm¿ Sweden

    Description

    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

    Reason

    The recalled devices labeling and instructions for use contain unapproved medical claims.

    Action

    Devices in the rental fleet will be delivered to the customer with revised documents including the updated information. The customers who purchased the devices will be notified of the recall via letter sent by registered mail. The field correction notice will include a recall letter, response form, and updated labeling.

    Distribution

    Worldwide Distribution. US nationwide, Germany, Austria, France, Italy, India, EU, Mexico, Switzerland, Canada, Saudi Arabia, Kuwait, Middle East, China, Japan, and Qatar.

    Quantity

    226 units