Device product
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
Z-1493-2019
Product summary
- Event
- Event 82727
- Status
- Terminated
- Classification
- Class II
- Quantity
- 317 units
- Official record key
device-enforcement:Z-1493-2019
Official wording
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 information: 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 pattern: 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
Derived failure modes
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Device software or design
Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may