BEUDAMED
    FDA Enforcement Class II Terminated

    TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

    Recall: Z-1493-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1493-2019
    Event ID
    82727
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories Inc. (St Jude Medical)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    June 5, 2019
    Initiation Date
    April 5, 2019
    Classification Date
    May 25, 2019
    Termination Date
    April 27, 2021
    Address
    One St. Jude Medical Drive, N/A, Saint Paul, MN, 55117, United States

    Description

    TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

    Reason

    In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.

    Code Info

    UDI: 07640157990194 Serial Numbers: 33019, 33059, 33350, 33354, 33357, 33360, 33361, 33363, 33390, 33392, 33393, 33405, 33417, 33421, 33444, 33449, 33451, 33457, 33458, 33461, 33491, 33492, 33509, 33013, 33015, 33020, 33040, 33075, 33091, 33097, 33160, 33197, 33384, 33385, 33387, 33389, 33414, 33433, 33388, 33435, 33481, 33154, 33157, 33162, 33163, 33278, 33092, 33159, 33437, 33412, 33014, 33027, 33028, 33029, 33038, 33049, 33057, 33082, 33096, 33192, 33222, 33268, 33379, 33383, 33397, 33398, 33399, 33400, 33422, 33423, 33478, 33320, 33352, 33395, 33351, 33069, 33381, 33455, 33064, 33093, 33313, 33337, 33161, 33426, 33083, 33321, 33420, 33051, 33155, 33196, 33256, 33353, 33460, 33217, 33427, 33073, 33150, 33076, 33148, 33434, 33396, 33050, 33333, 33333, 33336, 33336, 33095, 33143, 33143, 33112, 33113, 33266, 33267, 33269, 33270, 33271, 33272, 33273, 33274, 33275, 33276, 33283, 33287, 33288, 33291, 33325, 33356, 33359, 33362, 33404, 33459, 33016, 33098, 33099, 33100, 33101, 33102, 33103, 33104, 33105, 33106, 33107, 33108, 33110, 33111, 33127, 33130, 33131, 33265, 33018, 33024, 33025, 33087, 33152, 33156, 33220, 33230, 33231, 33254, 33279, 33281, 33315, 33416, 33428, 33438, 33439, 33442, 33443, 33463, 33330, 33386, 33228, 33033, 33048, 33149, 33259, 33282, 33464, 33022, 33031, 33035, 33037, 33044, 33045, 33046, 33055, 33066, 33067, 33068, 33078, 33080, 33085, 33086, 33088, 33094, 33129, 33137, 33138, 33140, 33144, 33158, 33195, 33218, 33221, 33229, 33253, 33257, 33262, 33280, 33289, 33293, 33326, 33328, 33355, 33364, 33382, 33403, 33406, 33408, 33409, 33411, 33424, 33431, 33440, 33445, 33446, 33448, 33450, 33454, 33462, 33465, 33466, 33169, 33011, 33012, 33021, 33023, 33034, 33054, 33056, 33074, 33079, 33089, 33090, 33109, 33191, 33193, 33194, 33215, 33224, 33314, 33316, 33327, 33329, 33358, 33375, 33376, 33407, 33415, 33419, 33429, 33447, 33219, 33258, 33292, 33334, 33335, 33032, 33410, 33081, 33170, 33171, 33172, 33173, 33198, 33199, 33201, 33203, 33204, 33205, 33206, 33207, 33208, 33209, 33210, 33211, 33212, 33213, 33214, 33294, 33295, 33296, 33298, 33299, 33300, 33301, 33302, 33303, 33304, 33365, 33366, 33367, 33368, 33369, 33370, 33371, 33372, 33373, 33374, 33549, 33550, 33551, 33168, 33165, 33216, 33042, 33456, 33070, 33432, 33480, 33047, 33072, 33077, 33136, 33226, 33263, 33377, 33378,

    Distribution

    US, UNITED KINGDOM, UAE, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDIA ARABIA, RUSSIA, ROMANIA, PORTUGAL, POLAND, PALESTINE, OMAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAN, GREECE, GERMANY, FRANCE, EL SALVADOR, EGYPT, DENMARK, Czech Republic, CHINA, CANADA, BULGARIA, BELGIUM, AUSTRIA, AUSTRALIA

    Quantity

    317 units