BEUDAMED
    FDA Enforcement Class II Ongoing

    ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

    Recall: Z-1836-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1836-2020
    Event ID
    85166
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 6, 2020
    Initiation Date
    March 6, 2020
    Classification Date
    April 30, 2020
    Address
    Akandevej 21, N/A, Bronshoj, N/A, N/A, Denmark

    Description

    ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

    Reason

    Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.

    Code Info

    Serial Numbers: 902-754R2692N002 and 902-754R2692N001

    Distribution

    US: in the state of California

    Quantity

    2 units