Z-1493-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2019
- Initiation Date
- April 5, 2019
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 317 units
Product Description
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
Reason for Recall
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.
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
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,