BEUDAMED
    FDA Enforcement Class II Terminated

    RX Imola, Model Nos. RX4900

    Recall: Z-2084-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2084-2019
    Event ID
    83175
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    June 24, 2019
    Classification Date
    July 25, 2019
    Termination Date
    May 21, 2020
    Address
    Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, N/A, United Kingdom

    Description

    RX Imola, Model Nos. RX4900

    Reason

    There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.

    Code Info

    All serial numbers

    Distribution

    Domestic distribution to CA CT MA MD MO NC NJ NY OH PA UT WV and PR. Worldwide foreign distribution.

    Quantity

    27