BEUDAMED
    FDA Enforcement Class II Terminated

    Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

    Recall: Z-1187-2013 · Reported May 8, 2013

    Enforcement

    Recall Number
    Z-1187-2013
    Event ID
    64812
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Masimo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2013
    Initiation Date
    March 13, 2013
    Classification Date
    April 29, 2013
    Termination Date
    June 10, 2015
    Address
    Forty Parker, Irvine, CA, 92618, United States

    Description

    Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).

    Reason

    Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.

    Code Info

    Catalog Number 9190 9193 9191 9192 9212 9213 9218 9219 9224 9282 9285 2883 9194

    Distribution

    Worldwide Distribution - USA (nationwide) including the countries of Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and Middle East / SW Asia.

    Quantity

    42,908 units