BEUDAMED
    FDA Recall Terminated

    Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.

    Recall: Z-0848-2014 · Initiated December 5, 2013

    Recall

    Recall Number
    Z-0848-2014
    Event Number
    67100
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    BTI
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    December 5, 2013
    Posted
    January 28, 2014
    Terminated
    February 5, 2015
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.

    Reason

    Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.

    Action

    Maquet sent a product recall urgent-medical device field correction letter/customer fax response via Fed Ex on December 5, 2013, to their customers. Customers are advised of the issues with the device and provided instructions. The correction will include an update with replacement of the affected connector and if needed replacement of the thermoelectric cooler if it damaged. These operations will be performed by an authorized Maquet representative. Any questions can be directed to customer service at 1-888-627-8383 option 2 followed by option 3 Monday through Friday between the hours of 8 am and 6 pm EST. Customers should completed and return the enclosed confirmation form or scan a copy to field [email protected] or fax (973) 807-9290.

    Distribution

    Worldwide Distribution US, Canada and Japan.

    Quantity

    237 units