BEUDAMED
    FDA Recall Terminated

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    Recall: Z-0871-2014 · Initiated December 19, 2013

    Recall

    Recall Number
    Z-0871-2014
    Event Number
    67243
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 19, 2013
    Posted
    January 30, 2014
    Terminated
    June 12, 2014
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216

    Description

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    Reason

    The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (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.

    Action

    On January 6, 2014, Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare AriaTele Model 96281 with SpO2 Option C" letter, dated 03 January 2014 to US consignees. On January 9, 2014, Spacelabs e-mailed the "URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare AriaTele Model 96281 with SpO2 Option C" letter (translated as necessary), dated 03 January 2014, to foreign consignees. The letter described product, problem and actions to be taken. The Consignees where instructed to follow the "Advise on what action the clinician takes" on the letter. Spacelabs Healthcare will contact you at the earliest possible date to schedule a convenient tie for Spacelabs to correct all of your facility's affected transmitters (software update) at no cost. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, GA, IA, IL, LA, MA, ME, MI, MO, MS, NY, PA, SC, TN, TX, VA, and Puerto Rico; and Internationally to: Canada, Chile, and Panama.

    Quantity

    1057 units (988 in the US and 69 outside of the US).