BEUDAMED
    FDA Recall Terminated

    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

    Recall: Z-0172-2016 · Initiated September 3, 2015

    Recall

    Recall Number
    Z-0172-2016
    Event Number
    72211
    Firm
    Spacelabs Healthcare Inc
    FEI Number
    3010157426
    Product Code
    DXH
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    September 3, 2015
    Posted
    October 30, 2015
    Terminated
    September 7, 2016
    Address
    35301 SE Center St, Snoqualmie, WA, 98065-9216

    Description

    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.

    Reason

    When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.

    Action

    Spacelabs Healthcare sent an Urgent-Medical Device Correction letter, dated September 17, 2015 to US consignees (Hospital Administrator/Biomedical Manager/Office Manager). The firm plans to email a customer letter (translated as necessary) to international subsidiaries and distributors of record on 9/25/15. Customers were informed Spacelabs Healthcare will send a replacement CardioCall ECG Event Recorder(s) at no cost and a prepaid method to ease the return of the affected CardioCall device(s) back to Spacelabs. For additional information or technical assistance contact: Global Technical Support Spacelabs Healthcare, Ltd. 1 Harforde Court, John Tate Road Hertford SG13 7NW United Kingdom + 44 (0) 1992 507700 For USA Technical Support call 1-800-522-7025 and select 2 for Technical Support

    Distribution

    Worldwide Distribution - US Distribution in the states of Nebraska, South Carolina, and Washington and in the following countries of AUSTRALIA, BELGIUM, BOLIVIA, CANADA, CHILE, DENMARK, GERMANY, GUATEMALA, HONG KONG, ITALY, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, QATAR, SINGAPORE, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.

    Quantity

    275 devices (20 in US and 255 international) and 113 PCBAs (international only)