Home / Recalls / Abbott Laboratories Inc. (St Jude Medical) / Z-1493-2019

Z-1493-2019 Class II Terminated

Recalled by Abbott Laboratories Inc. (St Jude Medical) — Saint Paul, MN

FDA device recall Z-1493-2019 was initiated by Abbott Laboratories Inc. (St Jude Medical) on April 5, 2019 and is designated Class II. 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 int… The recall status is terminated (terminated April 27, 2021). Affected quantity: 317 units.

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,

Other recalls by Abbott Laboratories Inc. (St Jude Medical)

  • Z-1853-2021 Class II — v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H7 (May 5, 2021)
  • Z-1854-2021 Class II — v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, (May 5, 2021)
  • Z-1855-2021 Class II — WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 (May 5, 2021)
  • Z-1549-2021 Class II — NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000 (April 22, 2021)

FDA data resources