BEUDAMED
    FDA Enforcement Class II Terminated

    ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.

    Recall: Z-2714-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2714-2017
    Event ID
    77551
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arjo, Inc. dba ArjoHuntleigh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    July 19, 2017
    Initiation Date
    June 14, 2017
    Classification Date
    July 11, 2017
    Termination Date
    August 12, 2022
    Address
    2349 W Lake St, Addison, IL, 60101-6183, United States

    Description

    ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment.

    Reason

    Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.

    Code Info

    Model numbers: 526000-01, 526000-01P, 526000-02, 526000-02P. Serial numbers range from 1400028031 to 1600048470.

    Distribution

    Worldwide Distribution - US (Nationwide) and internationally to the following countries: United Kingdom, Australia, New Zealand, Japan, Italy, United Arab Emirates, France, Canada, Brazil, Austria, Saudi Arabia, Qatar, India, Switzerland, Bahrain, Kuwait, South Africa, Lebanon, Netherlands, Poland, Spain, Ecuador, Hong-Kong, Colombia, Malaysia, Paraguay, Mauritius, Cyprus, Greece, Oman, Norway, Ireland, Pakistan, Czech Republic, Mexico, Sweden, Tanzania, Hungary, Singapore, Jordan, Israel, Denmark, Chile, and Germany.

    Quantity

    40,675 units worldwide