BEUDAMED
    FDA Recall Terminated

    RX Daytona, Model Nos. RX4040 and RX4041

    Recall: Z-2083-2019 · Initiated June 24, 2019

    Recall

    Recall Number
    Z-2083-2019
    Event Number
    83175
    Firm
    Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
    FEI Number
    1000361607
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 24, 2019
    Terminated
    May 21, 2020

    Description

    RX Daytona, Model Nos. RX4040 and RX4041

    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.

    Action

    On June 24, 2019, the firm notified its customers of the recall through an Urgent Field Safety Notice. Customers were asked to take the following actions: If there is any sign of damage to the RCU lid or lid sensor " Switch of main analyser main power supply as soon as possible " Contact technical support immediately. " Discuss the contents of this notice with your Medical Director. " Display this notice in a prominent location near the instrument. " Complete and return the response form 12187-QA to [email protected] within five working days.

    Distribution

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

    Quantity

    3