BEUDAMED
    FDA Enforcement Class II Ongoing

    OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.

    Recall: Z-0501-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0501-2025
    Event ID
    95581
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OrganOx Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2024
    Initiation Date
    October 15, 2024
    Classification Date
    November 21, 2024
    Address
    Magdalen Centre, 1 Robert Robinson Avenue, Oxford, N/A, N/A, United Kingdom

    Description

    OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.

    Reason

    Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

    Code Info

    UDI-DI: 05060462240029 Serial numbers 511, 512, 514, 515, 516, 517, 518, 519, 520, 522, 523, 524, 525, 527, 528, 529, 530, 531, 533, 535, 536, 537

    Distribution

    California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.

    Quantity

    20 units