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FDAFDA · Food and drugs·Recall number Z-0824-2013

Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Published February 20, 2013 · Recall initiated: January 14, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

VS2+ screen may lock up and stop monitoring during patient use

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips Healthcare Inc.
Distributor
Worldwide Distribution - US Nationwide and the countries of: AUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE GERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA KUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND NORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES UNITED KINGDOM
Lot
Serial Numbers: CN14800428, CN14800429, CN14800430, CN14800431, CN14800432, CN14800433, CN14800434, CN14800435, CN14800436, CN14800437, CN14800438, CN14800439, CN14800440, CN14800756, CN14800763, CN14800764, CN14800765, CN14800772, CN14800773, CN14800822, CN14800823, CN14800824, CN14800979, CN14801332, CN21201423, CN21201625, CN21202029, CN21202030, CN21202031, CN21202032, CN21202033, CN21202034, CN21202234, CN21202239, CN21202240, CN21202241, CN21202242, CN21202243, CN21202317, CN21202320, CN21202347, CN21202348, CN21202349, CN21202350, CN21202351, CN21202376, CN21202435, CN21202606, CN21202607, CN21202862, CN21202863, CN21202883, CN21203006, CN21203007, CN21203008, CN21203009, CN21203010, CN21203073, CN21203180, CN21203304, CN21203307, CN21203308, CN21203309, CN21203310, CN21203311, CN21203312, CN21203707, CN21203781, CN21203794, CN21203795, CN21203796, CN21203797, CN21203949, CN21203950, CN21203951, CN21203952, CN21203953, CN21204204, CN21204205, CN21204206, CN21204207, CN21204208, CN21204209, CN21204210, CN21204211, CN21203057, CN14800484, CN14800744, CN14800745, CN14800746, CN21203044, CN21203045, CN21203068, CN21203069, CN21203070, CN21203071, CN14800485, CN14800486, CN14800749, CN14800750, CN14800751, CN14800752, CN14800770, CN14800771, CN14800893, CN21201756, CN21201757, CN21201758, CN21201759, CN21201760, CN21202164, CN21202165, CN21202166, CN21202167, CN21202168, CN21202169, CN21202170, CN21202171, CN21202172, CN21202173, CN21202174, CN21202175, CN21202176, CN21202177, CN21202178, CN21202202, CN21202610, CN21202864, CN21203209, CN21203210, CN21203639, CN14801200, CN14801201, CN14801202, CN14801203, CN14801204, CN14801205, CN14801206, CN14801207, CN14801208, CN14801209, CN14801210, CN14801212, CN14801213, CN14801217, CN14801278, CN14801279, CN14801280, CN14801281, CN21201576, CN21201613, CN21202313, CN21202367, CN21202368, CN21202371, CN21202657, CN21203072, CN21203416, CN21203887, CN21203961, CN21203970, CN21204148, CN21204318, CN21202393, CN21202394, CN21203746, CN21203747, CN21203748, CN21203749, CN21201924, CN21201925, CN21201926, CN21201927, CN21201928, CN21201929, CN21201930, CN21201931, CN21201932, CN21201942, CN21202263, CN21202264, CN21202669, CN21202727, CN21202728, CN21202729, CN21202730, CN21202819, CN21202842, CN21202843, CN21202844, CN21202845, CN21202846, CN21202847, CN21202848, CN21202849, CN21202850, CN21202851, CN21202852, CN21202853, CN21202854, CN21202855, CN21202856, CN21202926, CN21202927, CN21202928, CN21202929, CN21202930, CN21202931, CN21202932, CN21202933, CN21202934, CN21202935, CN21202936, CN21202937, CN21202938, CN21202939, CN21202940, CN21202941, CN21202942, CN21202943, CN21202944, CN21202945, CN21202946, CN21202947, CN21202948, CN21202949, CN21202950, CN21202951, CN21202952, CN21202953, CN21202954, CN21202955, CN21202956, CN21202957, CN21202958, CN21202959, CN21202960, CN21202961, CN21202962, CN21202963, CN21202964, CN21202965, CN21202966, CN21202967, CN21202968, CN21202969, CN21202970, CN21202971, CN21202972, CN21202973, CN21202974, CN21202975, CN21202976, CN21202977, CN21202978, CN21202979, CN21202980, CN21202981, CN21202982, CN21202983, CN21202984, CN21202985, CN21202986, CN21202987, CN21202988, CN21202989, CN21202990, CN21202991, CN21203197, CN21203198, CN21203199, CN21203200, CN21203201, CN21203202, CN21203203, CN21203204, CN21203205, CN21203206, CN21203340, CN21203341, CN21203342, CN21203343, CN21203344, CN21203345, CN21203346, CN21203347, CN21203348, CN21203349, CN21203350, CN21203351, CN21203352, CN21203353, CN21203354, CN21203355, CN21203356, CN21203357, CN21203358, CN21203359, CN21203360, CN21203725, CN21203726, CN21203727, CN21203728, CN21203729, CN21203730, CN21203731, CN21203740, CN21204314, CN21202373, CN14800478, CN14800481, CN14800637, CN14800699, CN14800700, CN14800891, CN14800892, CN14800968, CN14800969, CN14800976, CN14800977, CN14800978, CN14800985, CN21201578, CN21201579, CN21201749, CN21201750, CN21201751, CN21201752, CN21202193, CN21202214, CN21202215, CN21202216,
Risk classification
Class II
Area (FDA)
device
Country
United States

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