BEUDAMED
    FDA Recall Terminated

    Tru-Link DIN unshielded ECG cable, 5-lead

    Recall: Z-0063-06 · Initiated September 16, 2005

    Recall

    Recall Number
    Z-0063-06
    Event Number
    33458
    Firm
    Spacelabs Medical Incorporated
    FEI Number
    3010157426
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 16, 2005
    Posted
    November 3, 2005
    Terminated
    February 14, 2006
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Tru-Link DIN unshielded ECG cable, 5-lead

    Reason

    ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.

    Action

    On 9/16/05 the firm sent a letter to their customers advising of the problem. The customer was requested to check the code on their cables, and if the suspect code, discard the cable. The customer was provided a response sheet to indicate they received the notification and to request new cables.

    Distribution

    Cables were distributed to 9 US hospitals/medical centers and 30 international customers.

    Quantity

    632 cables