BEUDAMED
    FDA Enforcement Class II Terminated

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.

    Recall: Z-2586-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2586-2014
    Event ID
    69125
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 10, 2014
    Initiation Date
    July 2, 2014
    Classification Date
    September 4, 2014
    Termination Date
    October 16, 2014
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216, United States

    Description

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.

    Reason

    The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.

    Code Info

    Serial numbers: 6281-002500, 6281-002501, 6281-002659, 6281-002661, 6281-002662, 6281-002663, 6281-002664, and 6281-003056. Model 96281, with SpO2 Option C.

    Distribution

    US Distribution to TX.

    Quantity

    8 units