BEUDAMED
    FDA Recall Terminated

    Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25. The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of healthcare.

    Recall: Z-2211-2009 · Initiated July 23, 2009

    Recall

    Recall Number
    Z-2211-2009
    Event Number
    53124
    Firm
    Spacelabs Healthcare, Incorporated
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 23, 2009
    Posted
    September 11, 2009
    Terminated
    July 21, 2011
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided with some Spacelabs' monitors. The kit PNs are: 718-0017-10, 718-0017-11, 718-0017-12, and 718-0017-13. The cables are also offered as replacement parts under Spacelabs PNs: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25. The Spacelabs elance Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of healthcare.

    Reason

    The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock.

    Action

    Spacelabs Healthcare issued an "Urgent: Medical Device Recall" dated July 20, 2009. Consignees are being sent replacement ECG cables for each item ordered and are requested to replace the affected cables. Also, they are instructed to destroy and dispose of the recalled cables according to their own protocol or local regulations. For further information, contact Spacelabs Healthcare Technical Support at 1-800-522-7025, option 2 (US) or +86-512-87171888, extension 304 (outside US).

    Distribution

    International Distribution -- Bangladesh, Turkey, Trinidad and Tobago, Romania, Guatemala, Algeria, Netherlands, Egypt, Chile, Venezuela, Spain, Colombia, India, the United Kingdom, Singapore, France and Ecuador.

    Quantity

    1,395