BEUDAMED
    FDA Enforcement Class I Ongoing

    Dr¿ger Perseus A500 Anesthesia Workstation

    Recall: Z-1512-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1512-2024
    Event ID
    94269
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2024
    Initiation Date
    March 20, 2024
    Classification Date
    April 18, 2024
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Dr¿ger Perseus A500 Anesthesia Workstation

    Reason

    Unexpected shutdown while operating on battery power.

    Code Info

    Material No. MX06000; UDI-DI: 04048675253600; All Serial No.

    Distribution

    Domestic: Nationwide Distribution; Foreign: Angola, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-se- S, Bulgaria, Canada, Chili, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, French Guiana, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Liechtenstein, Lithuania, Malaysia, Maldives, Mauritius, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Uganda, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.

    Quantity

    16,841 units