BEUDAMED
    FDA Enforcement Class II 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 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0172-2016
    Event ID
    72211
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spacelabs Healthcare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2015
    Initiation Date
    September 3, 2015
    Classification Date
    October 27, 2015
    Termination Date
    September 7, 2016
    Address
    35301 SE Center St, N/A, Snoqualmie, WA, 98065-9216, United States

    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.

    Code Info

    PCBAs PN #: 670-1670-00. SERIAL NUMBERS in the US: CARD-200990, CARD-201287, CARD-623478, CARD-623775, CARD-624198, CARD-624224, CARD-624314, CARD-624387, CARD-624404, CARD-624413, CARD-624891, CARD-625061, CARD-625089, CARD-625124, CARD-625232, CARD-625269, CARD-625296, CARD-625304, CARD-625322, and CARD-625421. SERIAL NUMBERS OUTSIDE THE US: CARD-000019, CARD-000028, CARD-000037, CARD-000046, CARD-000064, CARD-000073, CARD-000073, CARD-000082, CARD-000091, CARD-000109, CARD-000118, CARD-000127, CARD-000136, CARD-000145, CARD-000163, CARD-000172, CARD-000181, CARD-000190, CARD-000208, CARD-000217, CARD-000226, CARD-000235, CARD-000244, CARD-000271, CARD-000280, CARD-000299, CARD-000307, CARD-000325, CARD-000334, CARD-000343, CARD-000352, CARD-000361, CARD-000370, CARD-000398, CARD-000406, CARD-000415, CARD-000424, CARD-000433, CARD-000442, CARD-000451, CARD-000479, CARD-000479, CARD-000488, CARD-000497, CARD-000505, CARD-000514, CARD-000523, CARD-000532, CARD-000550, CARD-000578, CARD-000596, CARD-000604, CARD-000613, CARD-000622, CARD-000631, CARD-000640, CARD-000659, CARD-000668, CARD-000677, CARD-000686, CARD-000703, CARD-000721, CARD-000730, CARD-000749, CARD-000758, CARD-000767, CARD-000776, CARD-000785, CARD-000785, CARD-000794, CARD-000802, CARD-000811, CARD-000820, CARD-000820, CARD-000839, CARD-000848, CARD-000857, CARD-000866, CARD-000875, CARD-000893, CARD-000910, CARD-000910, CARD-000929, CARD-000938, CARD-000947, CARD-000956, CARD-000974, CARD-000983, CARD-000992, CARD-001009, CARD-001018, CARD-001027, CARD-001027, CARD-001036, CARD-001045, CARD-001054, CARD-001063, CARD-001072, CARD-001072, CARD-001081, CARD-001090, CARD-001108, CARD-001117, CARD-001135, CARD-001144, CARD-001153, CARD-001171, CARD-001180, CARD-001199, CARD-001199, CARD-001207, CARD-001216, CARD-001225, CARD-001234, CARD-001243, CARD-001252, CARD-001261, CARD-001270, CARD-001289, CARD-001298, CARD-001306, CARD-001315, CARD-001333, CARD-001379, CARD-001388, CARD-001397, CARD-001405, CARD-001414, CARD-001423, CARD-001441, CARD-001603, CARD-002602, CARD-003304, CARD-003601, CARD-003908, CARD-005203, CARD-006103, CARD-200035, CARD-200116, CARD-200125, CARD-200486, CARD-200963, CARD-201016, CARD-201052, CARD-201124, CARD-201133, CARD-300016, CARD-300025, CARD-300034, CARD-300052, CARD-300070, CARD-300089, CARD-300098, CARD-300160, CARD-300188, CARD-300197, CARD-300205, CARD-300214, CARD-300223, CARD-300232, CARD-300269, CARD-300278, CARD-300313, CARD-300322, CARD-300331, CARD-300368, CARD-300395, CARD-300412, CARD-300421, CARD-300430, CARD-300458, CARD-300467, CARD-300476, CARD-300494, CARD-300511, CARD-300539, CARD-300548, CARD-300566, CARD-300576, CARD-300647, CARD-300656, CARD-300674, CARD-300692, CARD-300728, CARD-300755, CARD-300773, CARD-300782, CARD-300809, CARD-300818, CARD-300836, CARD-300881, CARD-300890, CARD-300917, CARD-300926, CARD-300944, CARD-301006, CARD-301042, CARD-301079, CARD-301114, CARD-301150, CARD-301178, CARD-301439, CARD-301484, CARD-400213, CARD-621894, CARD-623973, CARD-624846, CARD-625043, CARD-625160, CARD-625188, CARD-625250, CARD-625476, CARD-625511, CARD-625665, CARD-625818, CARD-627023, CARD-627546, CARD-627555, CARD-627564, CARD-627636, CARD-627645, CARD-627654, CARD-627663, CARD-627672, CARD-627708, CARD-627726, CARD-627744, CARD-627753, CARD-627771, CARD-627780, CARD-627834, CARD-627861, CARD-627898, CARD-627960, CARD-627997, CARD-628013, CARD-628031, CARD-628059, CARD-628077, CARD-628095, CARD-628112, CARD-628176, CARD-628220, CARD-628239, CARD-630065, CARD-630137, CARD-630146, CARD-630281, CARD-630443, CARD-630461, CARD-630498, CARD-630885, CARD-631235, CARD-631271, and CARD-631307.

    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)