BEUDAMED
    FDA Recall Terminated

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    Recall: Z-0188-2014 · Initiated October 17, 2013

    Recall

    Recall Number
    Z-0188-2014
    Event Number
    66726
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 17, 2013
    Posted
    November 8, 2013
    Terminated
    February 25, 2014
    Address
    35301 Se Center St, Snoqualmie, WA, 98065-9216

    Description

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    Reason

    Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.

    Action

    Spacelabs Healthcare sent the "URGENT -MEDICAL DEVICE CORRECTION Spacelabs Healthcare elance Vital Signs Monitor with Option S" letter, dated 01 November 2013, to the US consignee on November 1, 2013. Spacelabs Healthcare will send the customer letter (translated as necessary) to all international subsidiaries and distributors of record via email on November 6, 2013. USERS ARE ADVISED THAT: -They may not be able to monitor their patient's oxygen saturation because the monitor will not allow the TruLink SpO2 sensor to be connected. The clinician will be required to find an alternate method to monitor oxygen saturation. -They will be contacted at the earliest possible date to schedule a convenient time and Spacelabs will correct all of your facility's affected monitors at no cost. Customer in the US can call Spacelabs Healthcare, Inc. of Snoqualmie, Washington at 800-522-7025. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at +86 512 87178304 for Technical Support.

    Distribution

    Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.

    Quantity

    89 units total (1 in US and 88 International)