• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare SureSigns VS2

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Philips Healthcare SureSigns VS2
see related information
Date Posted February 14, 2013
Recall Status1 Open
Recall Number Z-0824-2013
Recall Event ID 64070
Premarket Notification
510(K) Number
K112652 
Product Classification System, Measurement, Blood-Pressure, Non-Invasive - Product Code DXN
Product 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.
Code Information 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, CN21202217, CN21202218, CN21202219, CN21202220, CN21202221, CN21202222, CN21202223, CN21202224, CN21202225, CN21202226, CN21202227, CN21202309, CN21202515, CN21202516, CN21202517, CN21202518, CN21202523, CN21202524, CN21202667, CN21203213, CN21203367, CN21203398, CN21203399, CN21203736, CN21203737, CN21203738, CN21203739, CN21203744, CN21203745, CN21203937, CN21203959, CN21203960, CN21204118, CN21204120, CN21204214, CN21204215, CN21201789, CN21202306, CN21203368, CN21203369, CN14800427, CN14800479, CN14800480, CN14800482, CN14800801, CN14801215, CN14801360, CN21201371, CN21201372, CN21201417, CN21201418, CN21201420, CN21201422, CN21201622, CN21201623, CN21201624, CN21201770, CN21201786, CN21201941, CN21201989, CN21201995, CN21201996, CN21201997, CN21201998, CN21202099, CN21202100, CN21202101, CN21202229, CN21202230, CN21202231, CN21202359, CN21202440, CN21203011, CN21203012, CN21203013, CN21203033, CN21203212, CN21204007, CN21204008, CN21204009, CN21204010, CN21204011, CN21204313, CN21201787, CN21201788, CN21203055, CN21203158, CN21203159, CN21204016, CN21204017, CN21204018, CN21204019, CN21204020, CN21204021, CN21204305, CN14800418, CN21202683, CN21201362, CN21201429, CN21201430, CN21201431, CN21201432, CN21201433, CN21201434, CN21201435, CN21201436, CN21201437, CN21201438, CN21201496, CN21201614, CN21201952, CN21201953, CN21202659, CN21202666, CN21203299, CN21204331, CN14800382, CN21204223, CN21201936, CN21201937, CN21201938, CN21202857, CN21202858, CN21202859, CN21202860, CN21202861, CN14801216, CN21202051, CN21202391, CN21202392, CN21202885, CN21201991, CN21202142, CN21202192, CN21202198, CN21203186, CN21203187, CN21203188, CN21203804, CN21203805, CN21203806, CN21203807, CN21203808, CN21203809, CN21203810, CN21203811, CN21203812, CN21203813, CN21203814, CN21203815, CN21203816, CN21203817, CN21203818, CN21203819, CN21203820, CN21203821, CN21203822, CN21203823, CN14800827, CN21201427, CN21201428, CN21201497, CN21201498, CN21201499, CN21202210, CN21202211, CN21202212, CN21202213, CN21204117, CN21203993, CN21203994, CN21201784, CN21201785, CN21202251, CN21202865, CN21202866, CN21203035, CN21203036, CN21203037, CN21203038, CN21203039, CN21203170, CN21203181, CN21203985, CN21204146, CN21204147, CN21204200, CN21204329, CN21203207, CN21203208, CN14801340, CN14801341, CN14801342, CN14801343, CN14801344, CN14801345, CN14801346, CN14801347, CN14801348, CN14801349, CN14801350, CN14801351, CN14801352, CN14801353, CN14801354, CN14801355, CN14801356, CN14801357, CN14801358, CN14801359, CN21202082, CN21202083, CN21202084, CN21202085, CN21202086, CN21202087, CN21202088, CN21202089, CN21202090, CN21202091, CN21203929, CN21203930, CN21203931, CN21203932, CN21203933, CN21201364, CN21201365, CN21201366, CN21202125, CN21202126, CN21202127, CN21202128, CN21202129, CN21202130, CN21202131, CN21202132, CN21202133, CN21202134, CN21204022, CN21204023, CN21204024, CN21204025, CN21204026, CN21201577, CN14801282, CN14801283, CN14801284, CN14801285, CN14801286, CN14801287, CN14801288, CN14801289, CN14801290, CN14801291, CN14801292, CN14801293, CN14801294, CN14801295, CN14801296, CN14801297, CN14801298, CN14801299, CN14801300, CN14801301, CN14801302, CN14801303, CN14801304, CN14801305, CN14801306, CN14801307, CN14801308, CN14801309, CN14801310, CN14801311, CN14801312, CN14801313, CN14801314, CN14801315, CN14801316, CN14801317, CN14801318, CN14801319, CN14801320, CN14801321, CN14801322, CN14801323, CN14801324, CN14801325, CN14801326, CN14801327, CN14801328, CN14801329, CN14801330, CN14801331, CN21202145, CN21202146, CN21202147, CN21202148, CN21202149, CN21202290, CN21202291, CN21202292, CN21202293, CN21202294, CN21202295, CN21202296, CN21202297, CN21202298, CN21202299, CN21202300, CN21202301, CN21202302, CN21201504, CN21203222, CN14800846, CN21201413, CN21201414, CN21201983, CN21202289, CN21202715, CN21202716, CN21203024, CN21203025, CN21203026, CN21203027, CN21203028, CN21203029, CN21203030, CN21203040, CN21203041, CN21203042, CN21203043, CN21203211, CN21203226, CN21203227, CN21203228, CN21203229, CN21203230, CN21203231, CN21203253, CN21203254, CN21203255, CN21203256, CN21203257, CN21203258, CN21203259, CN21203260, CN21203261, CN21203262, CN21203263, CN21203264, CN21203265, CN21203266, CN21203267, CN21203268, CN21203269, CN21203270, CN21203271, CN21203272, CN21203273, CN21203274, CN21203275, CN21203276, CN21203298, CN21203300, CN21203303, CN21203317, CN21203318, CN21203319, CN21203320, CN21203321, CN21203322, CN21203402, CN21203403, CN21203637, CN21204128, CN21204218, CN21204243, CN21204244, CN21204245, CN21204246, CN21204247, CN21204248, CN21204249, CN21204250, CN21204251, CN21204252, CN21204253, CN21204254, CN21204255, CN21204256, CN21204257, CN21204258, CN21204259, CN21204260, CN21204261, CN21204262, CN21204263, CN21204264, CN21204265, CN21204266, CN21204267, CN21204268, CN21204269, CN21204273, CN21204274, CN21204288, CN21204289, CN21204290, CN21204330, CN21204375, CN21204376, CN21201571, CN21201572, CN21203056, CN21203708, CN14800417, CN14800422, CN14800423, CN14800424, CN14800489, CN14800490, CN14800491, CN14800492, CN14800493, CN14800494, CN14800495, CN14800496, CN14800497, CN14800498, CN14800499, CN14800500, CN14800501, CN14800502, CN14800503, CN14800504, CN14800505, CN14800506, CN14800507, CN14800508, CN14800509, CN14800510, CN14800511, CN14800512, CN14800513, CN14800514, CN14800515, CN14800516, CN14800517, CN14800518, CN14800519, CN14800520, CN14800521, CN14800522, CN14800523, CN14800524, CN14800525, CN14800526, CN14800527, CN14800528, CN14800529, CN14800530, CN14800531, CN14800532, CN14800533, CN14800534, CN14800535, CN21201397, CN21201398, CN21201399, CN21201400, CN21201401, CN21201402, CN21201403, CN21201404, CN21201405, CN21201406, CN21201407, CN21202068, CN21202069, CN21202070, CN21202071, CN21202072, CN21202073, CN21202074, CN21202075, CN21202076, CN21202077, CN21202078, CN21202079, CN21202080, CN21202081, CN21202143, CN21202144, CN21202324, CN21202325, CN21202326, CN21202327, CN21202328, CN21202329, CN21202330, CN21202331, CN21202332, CN21202333, CN21202334, CN21202335, CN21202336, CN21202377, CN21202378, CN21202379, CN21202380, CN21202381, CN21202382, CN21202383, CN21202437, CN21202438, CN21204125, CN21204126, CN21204127, CN21204195, CN21204196, CN21204197, CN21204198, CN21204199, CN21202120, CN21202121, CN21202122, CN21202123, CN21202124, CN21202135, CN21202136, CN21202137, CN21202138, CN21202139, CN21202308, CN21203034, CN21203184, CN21203185, CN21203986, CN21204129, CN21204130, CN21204272, CN21204293, CN14800215, CN14800216, CN14800412, CN14800413, CN21201827, CN21202519, CN21202520, CN21202521, CN21202522, CN21202457, CN21202458, CN21202459, CN21202460, CN21202461, CN21202462, CN21202463, CN21202464, CN21202465, CN21202466, CN21202467, CN21202468, CN21202469, CN21202470, CN21202471, CN21202472, CN21202473, CN21202474, CN21202475, CN21202476, CN21202477, CN21202478, CN21202479, CN21202480, CN21203792, CN21203793, CN21203798, CN21203799, CN21203800, CN21203801, CN21203802, CN21203803, CN21202456, CN21203000, CN21203001, CN21203002, CN21203003, CN21203004, CN21203005, CN21203989, CN21203990, CN21203991, CN21203992, CN14800847, CN14800848, CN14800849, CN14800850, CN14800851, CN14800852, CN14800853, CN14800854, CN14800855, CN14800856, CN14800857, CN14800858, CN14800859, CN14800860, CN14800861, CN14800862, CN14800863, CN14800864, CN14800865, CN14800866, CN14800867, CN14800868, CN14800869, CN14800870, CN14800871, CN14800872, CN14800873, CN14800874, CN14800875, CN14800876, CN14800877, CN14800878, CN14800879, CN14800880, CN14800881, CN14800882, CN14800883, CN14800884, CN14800885, CN14800894, CN14800895, CN14800896, CN14800897, CN14800898, CN14800899, CN14800900, CN14800901, CN14800902, CN14800903, CN14800904, CN14800905, CN14800906, CN14800907, CN14800908, CN14800909, CN14800910, CN14800911, CN14800912, CN14800913, CN14800914, CN14800915, CN14800916, CN14800917, CN14800918, CN14800919, CN14800920, CN14800921, CN14800922, CN14800923, CN14800924, CN14800925, CN14800926, CN14800927, CN14800928, CN14800929, CN14800930, CN14800931, CN14800932, CN14800933, CN14800934, CN14800935, CN14800936, CN14800937, CN14800938, CN14800939, CN14800940, CN14800941, CN14800942, CN14800945, CN14800946, CN14800949, CN14800950, CN14800951, CN14800952, CN14800953, CN14800954, CN14800955, CN14800956, CN14800957, CN14800958, CN14800959, CN14800960, CN14800961, CN14800962, CN14800963, CN14800964, CN21201444, CN21201445, CN21201446, CN21201447, CN21201448, CN21201449, CN21201450, CN21201451, CN21201452, CN21201453, CN21201454, CN21201455, CN21201456, CN21201457, CN21201458, CN21201459, CN21201460, CN21201461, CN21201462, CN21201463, CN21201464, CN21201465, CN21201466, CN21201467, CN21201468, CN21201469, CN21201470, CN21201471, CN21201472, CN21201473, CN21201474, CN21201475, CN21201476, CN21201477, CN21201478, CN21201479, CN21201480, CN21201481, CN21201482, CN21201483, CN21201484, CN21201485, CN21201486, CN21201487, CN21201488, CN21201489, CN21201490, CN21201491, CN21201795, CN21202415, CN21202416, CN21202721, CN21202722, CN21202732, CN21202733, CN21202734, CN21202735, CN21202736, CN21202737, CN21202738, CN21202739, CN21202740, CN21202741, CN21202742, CN21202743, CN21202744, CN21204149, CN21204150, CN21204151, CN21204152, CN21204153, CN21204154, CN21204155, CN21204156, CN21204157, CN21204158, CN21204159, CN21204160, CN21204161, CN21204162, CN21204163, CN21204164, CN21204165, CN21204166, CN21204167, CN21204168, CN21204169, CN21204170, CN21204171, CN21204172, CN21204173, CN21204174, CN21204175, CN21204176, CN21204177, CN21204178, CN21204179, CN21204180, CN21204181, CN21204182, CN21204183, CN21204184, CN21204185, CN21204186, CN21204187, CN21204188, CN21204189, CN21204190, CN21204191, CN21204192, CN21204193, CN21204194, CN21204135, CN21204136, CN21204137, CN14800748, CN14800754, CN14800755, CN14800986, CN14800987, CN21201761, CN21201762, CN21202056, CN21202057, CN21202058, CN21202059, CN21202060, CN21202061, CN21202062, CN21202063, CN21202064, CN21202065, CN21202066, CN21202067, CN21202194, CN21202195, CN21202196, CN21202436, CN21202886, CN21202887, CN21202888, CN21202889, CN21202890, CN21202891, CN21202892, CN21202893, CN21202894, CN21202895, CN21202896, CN21202897, CN21202898, CN21202899, CN21202900, CN21202901, CN21202902, CN21202903, CN21202904, CN21202905, CN21202906, CN21202907, CN21202908, CN21202909, CN21202910, CN21202911, CN21202912, CN21202913, CN21202914, CN21202915, CN21202916, CN21202917, CN21202918, CN21202919, CN21202920, CN21202921, CN21202922, CN14800101, CN14800102, CN14800103, CN14800104, CN14800105, CN14800106, CN14800107, CN14800108, CN14800109, CN14800110, CN14800111, CN14800112, CN14800113, CN14800114, CN14800115, CN14800116, CN14800117, CN14800118, CN14800119, CN14800120, CN14800121, CN14800122, CN14800123, CN14800124, CN14800125, CN14800126, CN14800127, CN14800128, CN14800129, CN14800130, CN14800131, CN14800132, CN14800133, CN14800134, CN14800135, CN14800136, CN14800148, CN14800149, CN14800150, CN14800151, CN14800152, CN14800153, CN14800154, CN14800155, CN14800156, CN14800157, CN14800158, CN14800159, CN14800160, CN14800161, CN14800162, CN14800163, CN14800164, CN14800165, CN14800166, CN14800167, CN14800168, CN14800169, CN14800170, CN14800171, CN14800172, CN14800173, CN14800174, CN14800175, CN14800176, CN14800177, CN14800178, CN14800179, CN14800180, CN14800181, CN14800182, CN14800183, CN14800184, CN14800185, CN14800186, CN14800187, CN14800188, CN14800189, CN14800190, CN14800191, CN14800192, CN14800193, CN14800194, CN14800195, CN14800196, CN14800197, CN14800198, CN14800199, CN14800200, CN14800201, CN14800202, CN14800203, CN14800204, CN14800205, CN14800206, CN14800207, CN14800208, CN14800209, CN14800210, CN14800211, CN14800212, CN14800213, CN14800214, CN14800217, CN14800218, CN14800219, CN14800220, CN14800221, CN14800222, CN14800223, CN14800224, CN14800225, CN14800226, CN14800227, CN14800228, CN14800229, CN14800230, CN14800231, CN14800232, CN14800233, CN14800234, CN14800235, CN14800236, CN14800237, CN14800238, CN14800239, CN14800240, CN14800241, CN14800242, CN14800243, CN14800244, CN14800245, CN14800246, CN14800247, CN14800248, CN14800249, CN14800250, CN14800251, CN14800252, CN14800253, CN14800254, CN14800255, CN14800256, CN14800257, CN14800258, CN14800259, CN14800260, CN14800261, CN14800262, CN14800263, CN14800264, CN14800265, CN14800266, CN14800267, CN14800268, CN14800269, CN14800270, CN14800271, CN14800272, CN14800273, CN14800274, CN14800275, CN14800276, CN14800277, CN14800278, CN14800279, CN14800280, CN14800281, CN14800282, CN14800283, CN14800284, CN14800285, CN14800286, CN14800287, CN14800288, CN14800289, CN14800290, CN14800291, CN14800292, CN14800293, CN14800294, CN14800295, CN14800296, CN14800297, CN14800298, CN14800299, CN14800300, CN14800301, CN14800302, CN14800303, CN14800304, CN14800305, CN14800306, CN14800307, CN14800308, CN14800309, CN14800310, CN14800311, CN14800312, CN14800313, CN14800314, CN14800315, CN14800316, CN14800317, CN14800318, CN14800319, CN14800320, CN14800321, CN14800322, CN14800323, CN14800324, CN14800325, CN14800326, CN14800327, CN14800328, CN14800329, CN14800330, CN14800331, CN14800332, CN14800333, CN14800334, CN14800335, CN14800336, CN14800337, CN14800338, CN14800339, CN14800340, CN14800341, CN14800342, CN14800343, CN14800344, CN14800345, CN14800346, CN14800347, CN14800348, CN14800349, CN14800350, CN14800351, CN14800352, CN14800353, CN14800354, CN14800355, CN14800356, CN14800357, CN14800358, CN14800359, CN14800360, CN14800361, CN14800362, CN14800363, CN14800364, CN14800365, CN14800366, CN14800367, CN14800368, CN14800369, CN14800370, CN14800371, CN14800372, CN14800373, CN14800374, CN14800375, CN14800376, CN14800377, CN14800378, CN14800379, CN14800380, CN14800381, CN14800409, CN14800410, CN14800411, CN14800414, CN14800415, CN14800416, CN14800419, CN14800420, CN14800425, CN14800426, CN14800474, CN14800475, CN14800476, CN14800477, CN14800483, CN14800487, CN14800488, CN14800539, CN14800611, CN14800612, CN14800613, CN14800614, CN14800615, CN14800616, CN14800617, CN14800618, CN14800619, CN14800620, CN14800621, CN14800622, CN14800623, CN14800624, CN14800625, CN14800626, CN14800627, CN14800628, CN14800629, CN14800630, CN14800631, CN14800632, CN14800633, CN14800634, CN14800635, CN14800636, CN14800638, CN14800639, CN14800640, CN14800641, CN14800642, CN14800643, CN14800644, CN14800645, CN14800646, CN14800647, CN14800648, CN14800649, CN14800650, CN14800654, CN14800655, CN14800656, CN14800657, CN14800658, CN14800659, CN14800660, CN14800661, CN14800662, CN14800663, CN14800664, CN14800665, CN14800666, CN14800667, CN14800668, CN14800669, CN14800670, CN14800671, CN14800672, CN14800673, CN14800674, CN14800675, CN14800676, CN14800677, CN14800678, CN14800679, CN14800680, CN14800681, CN14800682, CN14800683, CN14800684, CN14800685, CN14800686, CN14800687, CN14800688, CN14800689, CN14800690, CN14800691, CN14800692, CN14800693, CN14800694, CN14800695, CN14800696, CN14800697, CN14800698, CN14800701, CN14800702, CN14800703, CN14800704, CN14800705, CN14800706, CN14800707, CN14800708, CN14800709, CN14800710, CN14800711, CN14800712, CN14800713, CN14800714, CN14800715, CN14800716, CN14800718, CN14800719, CN14800726, CN14800727, CN14800728, CN14800729, CN14800730, CN14800731, CN14800732, CN14800733, CN14800734, CN14800735, CN14800736, CN14800737, CN14800738, CN14800739, CN14800740, CN14800741, CN14800742, CN14800743, CN14800766, CN14800767, CN14800768, CN14800769, CN14800774, CN14800775, CN14800776, CN14800777, CN14800778, CN14800779, CN14800780, CN14800781, CN14800782, CN14800783, CN14800784, CN14800785, CN14800786, CN14800787, CN14800788, CN14800789, CN14800790, CN14800791, CN14800792, CN14800794, CN14800804, CN14800805, CN14800806, CN14800807, CN14800808, CN14800809, CN14800810, CN14800811, CN14800812, CN14800813, CN14800814, CN14800815, CN14800816, CN14800817, CN14800818, CN14800819, CN14800820, CN14800821, CN14800825, CN14800826, CN14800832, CN14800947, CN14800948, CN14800965, CN14800966, CN14800970, CN14800971, CN14800974, CN14800975, CN14800980, CN14800981, CN14800982, CN14800983, CN14800984, CN14800989, CN14800990, CN14800991, CN14800992, CN14800993, CN14800994, CN14800995, CN14800996, CN14800997, CN14800998, CN14800999, CN14801000, CN14801001, CN14801002, CN14801003, CN14801004, CN14801005, CN14801006, CN14801007, CN14801008, CN14801009, CN14801010, CN14801011, CN14801012, CN14801013, CN14801014, CN14801015, CN14801016, CN14801017, CN14801018, CN14801019, CN14801020, CN14801021, CN14801022, CN14801023, CN14801024, CN14801025, CN14801026, CN14801027, CN14801028, CN14801029, CN14801030, CN14801031, CN14801032, CN14801033, CN14801034, CN14801035, CN14801036, CN14801037, CN14801038, CN14801039, CN14801040, CN14801041, CN14801042, CN14801043, CN14801044, CN14801045, CN14801046, CN14801047, CN14801048, CN14801049, CN14801050, CN14801051, CN14801052, CN14801053, CN14801054, CN14801055, CN14801056, CN14801057, CN14801058, CN14801059, CN14801060, CN14801061, CN14801062, CN14801063, CN14801064, CN14801065, CN14801066, CN14801067, CN14801068, CN14801069, CN14801070, CN14801071, CN14801072, CN14801073, CN14801074, CN14801075, CN14801076, CN14801077, CN14801078, CN14801079, CN14801080, CN14801081, CN14801082, CN14801083, CN14801084, CN14801085, CN14801086, CN14801087, CN14801088, CN14801089, CN14801090, CN14801091, CN14801092, CN14801093, CN14801094, CN14801095, CN14801096, CN14801097, CN14801098, CN14801099, CN14801100, CN14801101, CN14801102, CN14801103, CN14801104, CN14801105, CN14801106, CN14801107, CN14801108, CN14801109, CN14801110, CN14801111, CN14801112, CN14801113, CN14801114, CN14801115, CN14801116, CN14801117, CN14801118, CN14801119, CN14801120, CN14801121, CN14801122, CN14801123, CN14801124, CN14801125, CN14801126, CN14801127, CN14801128, CN14801129, CN14801130, CN14801131, CN14801132, CN14801133, CN14801134, CN14801135, CN14801136, CN14801137, CN14801138, CN14801139, CN14801140, CN14801141, CN14801142, CN14801143, CN14801144, CN14801145, CN14801146, CN14801147, CN14801148, CN14801149, CN14801150, CN14801151, CN14801152, CN14801153, CN14801154, CN14801155, CN14801156, CN14801157, CN14801158, CN14801159, CN14801160, CN14801161, CN14801162, CN14801163, CN14801164, CN14801165, CN14801166, CN14801167, CN14801168, CN14801169, CN14801170, CN14801171, CN14801172, CN14801173, CN14801174, CN14801175, CN14801176, CN14801177, CN14801178, CN14801179, CN14801180, CN14801181, CN14801182, CN14801183, CN14801184, CN14801185, CN14801186, CN14801187, CN14801188, CN14801189, CN14801190, CN14801218, CN14801219, CN14801220, CN14801221, CN14801222, CN14801223, CN14801224, CN14801225, CN14801226, CN14801227, CN14801228, CN14801229, CN14801230, CN14801231, CN14801232, CN14801233, CN14801234, CN14801235, CN14801236, CN14801237, CN14801238, CN14801239, CN14801240, CN14801241, CN14801242, CN14801243, CN14801244, CN14801245, CN14801246, CN14801247, CN14801248, CN14801249, CN14801250, CN14801251, CN14801252, CN14801253, CN14801254, CN14801255, CN14801256, CN14801257, CN14801258, CN14801259, CN14801260, CN14801261, CN14801262, CN14801263, CN14801264, CN14801265, CN14801266, CN14801267, CN14801268, CN14801269, CN14801270, CN14801271, CN14801272, CN14801273, CN21201367, CN21201368, CN21201369, CN21201370, CN21201408, CN21201409, CN21201410, CN21201411, CN21201412, CN21201415, CN21201416, CN21201419, CN21201421, CN21201424, CN21201425, CN21201553, CN21201554, CN21201555, CN21201556, CN21201557, CN21201558, CN21201559, CN21201560, CN21201561, CN21201562, CN21201563, CN21201564, CN21201565, CN21201566, CN21201567, CN21201604, CN21201605, CN21201606, CN21201607, CN21201608, CN21201609, CN21201610, CN21201611, CN21201612, CN21201615, CN21201616, CN21201617, CN21201627, CN21201628, CN21201629, CN21201630, CN21201631, CN21201632, CN21201633, CN21201634, CN21201635, CN21201636, CN21201637, CN21201638, CN21201639, CN21201640, CN21201641, CN21201642, CN21201643, CN21201644, CN21201645, CN21201646, CN21201647, CN21201648, CN21201649, CN21201650, CN21201651, CN21201652, CN21201653, CN21201654, CN21201655, CN21201656, CN21201657, CN21201658, CN21201659, CN21201660, CN21201661, CN21201662, CN21201663, CN21201664, CN21201665, CN21201666, CN21201667, CN21201668, CN21201669, CN21201670, CN21201671, CN21201672, CN21201673, CN21201674, CN21201675, CN21201676, CN21201677, CN21201678, CN21201679, CN21201680, CN21201681, CN21201682, CN21201683, CN21201684, CN21201685, CN21201686, CN21201687, CN21201688, CN21201689, CN21201690, CN21201691, CN21201692, CN21201693, CN21201694, CN21201695, CN21201696, CN21201697, CN21201698, CN21201699, CN21201700, CN21201701, CN21201702, CN21201703, CN21201704, CN21201705, CN21201706, CN21201707, CN21201708, CN21201709, CN21201710, CN21201711, CN21201712, CN21201713, CN21201714, CN21201715, CN21201716, CN21201717, CN21201718, CN21201719, CN21201720, CN21201721, CN21201722, CN21201723, CN21201724, CN21201725, CN21201726, CN21201727, CN21201728, CN21201729, CN21201730, CN21201731, CN21201732, CN21201733, CN21201734, CN21201735, CN21201736, CN21201737, CN21201738, CN21201739, CN21201740, CN21201741, CN21201742, CN21201743, CN21201744, CN21201745, CN21201746, CN21201747, CN21201748, CN21201768, CN21201769, CN21201828, CN21201855, CN21201856, CN21201857, CN21201933, CN21201934, CN21201935, CN21201939, CN21201940, CN21201943, CN21201944, CN21201945, CN21201949, CN21201950, CN21201951, CN21201954, CN21201955, CN21201956, CN21201957, CN21201958, CN21201959, CN21201960, CN21201961, CN21201962, CN21201963, CN21201964, CN21201965, CN21201966, CN21201967, CN21201968, CN21201969, CN21201970, CN21201971, CN21201972, CN21201980, CN21201981, CN21201984, CN21201985, CN21201990, CN21201999, CN21202000, CN21202001, CN21202002, CN21202003, CN21202004, CN21202005, CN21202006, CN21202007, CN21202008, CN21202009, CN21202010, CN21202011, CN21202012, CN21202013, CN21202014, CN21202015, CN21202016, CN21202017, CN21202018, CN21202019, CN21202020, CN21202021, CN21202022, CN21202023, CN21202024, CN21202025, CN21202026, CN21202027, CN21202028, CN21202035, CN21202036, CN21202037, CN21202038, CN21202043, CN21202044, CN21202045, CN21202046, CN21202047, CN21202048, CN21202049, CN21202050, CN21202055, CN21202092, CN21202102, CN21202103, CN21202104, CN21202105, CN21202106, CN21202107, CN21202108, CN21202109, CN21202140, CN21202141, CN21202179, CN21202190, CN21202191, CN21202197, CN21202199, CN21202200, CN21202201, CN21202235, CN21202245, CN21202265, CN21202266, CN21202267, CN21202268, CN21202269, CN21202270, CN21202271, CN21202272, CN21202279, CN21202280, CN21202281, CN21202282, CN21202283, CN21202284, CN21202285, CN21202286, CN21202287, CN21202288, CN21202310, CN21202311, CN21202312, CN21202316, CN21202318, CN21202319, CN21202321, CN21202322, CN21202353, CN21202360, CN21202384, CN21202385, CN21202386, CN21202387, CN21202388, CN21202389, CN21202390, CN21202421, CN21202422, CN21202423, CN21202424, CN21202425, CN21202426, CN21202427, CN21202428, CN21202429, CN21202430, CN21202431, CN21202432, CN21202433, CN21202434, CN21202439, CN21202525, CN21202603, CN21202604, CN21202605, CN21202608, CN21202609, CN21202611, CN21202660, CN21202661, CN21202662, CN21202663, CN21202664, CN21202665, CN21202700, CN21202701, CN21202702, CN21202712, CN21202713, CN21202714, CN21202717, CN21202718, CN21202724, CN21202725, CN21202726, CN21202745, CN21202746, CN21202747, CN21202748, CN21202749, CN21202750, CN21202751, CN21202752, CN21202753, CN21202754, CN21202755, CN21202756, CN21202875, CN21202876, CN21202877, CN21202878, CN21202879, CN21202880, CN21202881, CN21202882, CN21202998, CN21203014, CN21203015, CN21203016, CN21203017, CN21203065, CN21203066, CN21203067, CN21203096, CN21203097, CN21203098, CN21203099, CN21203100, CN21203101, CN21203102, CN21203103, CN21203104, CN21203105, CN21203106, CN21203107, CN21203108, CN21203109, CN21203110, CN21203111, CN21203112, CN21203113, CN21203114, CN21203115, CN21203116, CN21203117, CN21203118, CN21203119, CN21203120, CN21203121, CN21203122, CN21203123, CN21203124, CN21203125, CN21203126, CN21203127, CN21203162, CN21203163, CN21203164, CN21203165, CN21203166, CN21203167, CN21203168, CN21203169, CN21203182, CN21203183, CN21203277, CN21203301, CN21203302, CN21203305, CN21203306, CN21203315, CN21203316, CN21203325, CN21203326, CN21203327, CN21203328, CN21203329, CN21203330, CN21203331, CN21203332, CN21203333, CN21203334, CN21203335, CN21203336, CN21203370, CN21203371, CN21203372, CN21203373, CN21203374, CN21203375, CN21203376, CN21203377, CN21203378, CN21203379, CN21203380, CN21203381, CN21203382, CN21203388, CN21203389, CN21203390, CN21203391, CN21203392, CN21203418, CN21203419, CN21203420, CN21203421, CN21203422, CN21203423, CN21203424, CN21203425, CN21203426, CN21203427, CN21203428, CN21203429, CN21203430, CN21203431, CN21203432, CN21203433, CN21203434, CN21203435, CN21203436, CN21203437, CN21203438, CN21203439, CN21203440, CN21203441, CN21203442, CN21203443, CN21203444, CN21203445, CN21203446, CN21203447, CN21203448, CN21203449, CN21203450, CN21203451, CN21203452, CN21203453, CN21203454, CN21203455, CN21203456, CN21203457, CN21203458, CN21203459, CN21203460, CN21203461, CN21203468, CN21203469, CN21203470, CN21203471, CN21203472, CN21203473, CN21203474, CN21203475, CN21203476, CN21203477, CN21203478, CN21203479, CN21203480, CN21203481, CN21203482, CN21203483, CN21203484, CN21203485, CN21203486, CN21203487, CN21203488, CN21203489, CN21203490, CN21203491, CN21203492, CN21203493, CN21203494, CN21203495, CN21203496, CN21203497, CN21203498, CN21203504, CN21203505, CN21203506, CN21203507, CN21203508, CN21203509, CN21203510, CN21203511, CN21203512, CN21203513, CN21203514, CN21203515, CN21203516, CN21203517, CN21203518, CN21203519, CN21203520, CN21203521, CN21203522, CN21203523, CN21203524, CN21203525, CN21203526, CN21203527, CN21203528, CN21203529, CN21203530, CN21203531, CN21203532, CN21203533, CN21203534, CN21203535, CN21203536, CN21203537, CN21203538, CN21203539, CN21203540, CN21203541, CN21203542, CN21203543, CN21203544, CN21203545, CN21203546, CN21203547, CN21203548, CN21203549, CN21203550, CN21203551, CN21203552, CN21203553, CN21203554, CN21203555, CN21203556, CN21203557, CN21203558, CN21203559, CN21203560, CN21203561, CN21203562, CN21203563, CN21203564, CN21203565, CN21203566, CN21203567, CN21203568, CN21203569, CN21203570, CN21203571, CN21203572, CN21203573, CN21203574, CN21203575, CN21203576, CN21203577, CN21203578, CN21203579, CN21203580, CN21203581, CN21203582, CN21203583, CN21203584, CN21203585, CN21203586, CN21203587, CN21203588, CN21203589, CN21203590, CN21203591, CN21203592, CN21203593, CN21203594, CN21203595, CN21203596, CN21203597, CN21203598, CN21203599, CN21203600, CN21203601, CN21203602, CN21203603, CN21203604, CN21203605, CN21203606, CN21203607, CN21203608, CN21203609, CN21203610, CN21203611, CN21203612, CN21203613, CN21203614, CN21203615, CN21203616, CN21203619, CN21203620, CN21203621, CN21203622, CN21203623, CN21203624, CN21203625, CN21203640, CN21203641, CN21203642, CN21203643, CN21203644, CN21203645, CN21203646, CN21203647, CN21203648, CN21203649, CN21203650, CN21203651, CN21203652, CN21203653, CN21203654, CN21203655, CN21203656, CN21203657, CN21203658, CN21203659, CN21203660, CN21203661, CN21203662, CN21203663, CN21203664, CN21203665, CN21203666, CN21203667, CN21203668, CN21203669, CN21203670, CN21203671, CN21203672, CN21203673, CN21203674, CN21203675, CN21203676, CN21203677, CN21203678, CN21203679, CN21203680, CN21203681, CN21203682, CN21203683, CN21203684, CN21203685, CN21203686, CN21203687, CN21203688, CN21203689, CN21203690, CN21203691, CN21203692, CN21203693, CN21203694, CN21203695, CN21203696, CN21203697, CN21203698, CN21203699, CN21203700, CN21203701, CN21203704, CN21203705, CN21203715, CN21203716, CN21203717, CN21203718, CN21203719, CN21203720, CN21203721, CN21203722, CN21203723, CN21203724, CN21203732, CN21203733, CN21203734, CN21203735, CN21203742, CN21203743, CN21203780, CN21203828, CN21203839, CN21203840, CN21203841, CN21203842, CN21203843, CN21203844, CN21203845, CN21203846, CN21203847, CN21203848, CN21203849, CN21203850, CN21203851, CN21203852, CN21203853, CN21203854, CN21203855, CN21203856, CN21203857, CN21203858, CN21203859, CN21203860, CN21203861, CN21203862, CN21203863, CN21203864, CN21203865, CN21203866, CN21203867, CN21203868, CN21203869, CN21203886, CN21203926, CN21203927, CN21203928, CN21203938, CN21203939, CN21203940, CN21203941, CN21203942, CN21203943, CN21203944, CN21203945, CN21203967, CN21203968, CN21203969, CN21204005, CN21204013, CN21204029, CN21204030, CN21204031, CN21204032, CN21204033, CN21204034, CN21204035, CN21204036, CN21204037, CN21204038, CN21204039, CN21204040, CN21204041, CN21204049, CN21204050, CN21204051, CN21204052, CN21204053, CN21204054, CN21204055, CN21204056, CN21204057, CN21204058, CN21204059, CN21204060, CN21204061, CN21204062, CN21204063, CN21204064, CN21204065, CN21204066, CN21204067, CN21204068, CN21204069, CN21204070, CN21204071, CN21204072, CN21204073, CN21204074, CN21204075, CN21204076, CN21204077, CN21204078, CN21204079, CN21204080, CN21204081, CN21204082, CN21204083, CN21204084, CN21204085, CN21204086, CN21204087, CN21204088, CN21204089, CN21204090, CN21204091, CN21204092, CN21204093, CN21204094, CN21204095, CN21204096, CN21204097, CN21204098, CN21204099, CN21204100, CN21204101, CN21204119, CN21204131, CN21204134, CN21204144, CN21204145, CN21204201, CN21204202, CN21204224, CN21204226, CN21204283, CN21204284, CN21204285, CN21204286, CN21204287, CN21204292, CN21204309, CN21204310, CN21204311, CN21204312, CN21204317, CN21204322, SP13701043, USPP101007, CN21201390, CN21201500, CN21201501, CN21201502, CN21201503, CN21201505, CN21201506, CN21201507, CN21201508, CN21201509, CN21201510, CN21201511, CN21201512, CN21201513, CN21201514, CN21201515, CN21201516, CN21201517, CN21201518, CN21201519, CN21201520, CN21201521, CN21201522, CN21201523, CN21201524, CN21201525, CN21201526, CN21201527, CN21201528, CN21201529, CN21201530, CN21201531, CN21201532, CN21201533, CN21201534, CN21201535, CN21201536, CN21201537, CN21201538, CN21201539, CN21201540, CN21201541, CN21201542, CN21201543, CN21201544, CN21201545, CN21201546, CN21201568, CN21201569, CN21201570, CN21201580, CN21201581, CN21201582, CN21201583, CN21201584, CN21201585, CN21201586, CN21201587, CN21201588, CN21201589, CN21201590, CN21201591, CN21201592, CN21201593, CN21201594, CN21201595, CN21201596, CN21201597, CN21201598, CN21201599, CN21201600, CN21201601, CN21201602, CN21201619, CN21201620, CN21201621, CN21201763, CN21201764, CN21201765, CN21201766, CN21201767, CN21201790, CN21201791, CN21201792, CN21201793, CN21201794, CN21201800, CN21201801, CN21201802, CN21201803, CN21201815, CN21201816, CN21201817, CN21201818, CN21201819, CN21201820, CN21201821, CN21201822, CN21201823, CN21201824, CN21201829, CN21201830, CN21201831, CN21201832, CN21201833, CN21201834, CN21201835, CN21201836, CN21201837, CN21201838, CN21201839, CN21201840, CN21201841, CN21201842, CN21201843, CN21201872, CN21201873, CN21201874, CN21201875, CN21201876, CN21201877, CN21201878, CN21201879, CN21201880, CN21201881, CN21201882, CN21201883, CN21201884, CN21201885, CN21201902, CN21201903, CN21201904, CN21201905, CN21201906, CN21201907, CN21201908, CN21201909, CN21201910, CN21201911, CN21201912, CN21201913, CN21201914, CN21201915, CN21201916, CN21201986, CN21201987, CN21201992, CN21202039, CN21202093, CN21202162, CN21202163, CN21202203, CN21202204, CN21202205, CN21202236, CN21202237, CN21202323, CN21202339, CN21202340, CN21202341, CN21202342, CN21202343, CN21202344, CN21202346, CN21202374, CN21202375, CN21202395, CN21202396, CN21202397, CN21202398, CN21202399, CN21202400, CN21202401, CN21202402, CN21202403, CN21202404, CN21202405, CN21202406, CN21202407, CN21202408, CN21202409, CN21202410, CN21202411, CN21202412, CN21202413, CN21202414, CN21202481, CN21202482, CN21202483, CN21202484, CN21202485, CN21202486, CN21202487, CN21202488, CN21202489, CN21202490, CN21202491, CN21202492, CN21202493, CN21202494, CN21202495, CN21202496, CN21202497, CN21202498, CN21202499, CN21202500, CN21202501, CN21202502, CN21202503, CN21202504, CN21202505, CN21202506, CN21202507, CN21202508, CN21202509, CN21202510, CN21202511, CN21202512, CN21202513, CN21202514, CN21202670, CN21202671, CN21202672, CN21202673, CN21202674, CN21202675, CN21202681, CN21202682, CN21202684, CN21202685, CN21202686, CN21202687, CN21202841, CN21203031, CN21203046, CN21203047, CN21203048, CN21203049, CN21203050, CN21203051, CN21203052, CN21203053, CN21203074, CN21203075, CN21203076, CN21203077, CN21203078, CN21203079, CN21203080, CN21203081, CN21203082, CN21203083, CN21203084, CN21203085, CN21203086, CN21203087, CN21203088, CN21203089, CN21203090, CN21203091, CN21203092, CN21203093, CN21203094, CN21203095, CN21203154, CN21203155, CN21203156, CN21203157, CN21203189, CN21203190, CN21203191, CN21203192, CN21203193, CN21203194, CN21203214, CN21203215, CN21203216, CN21203217, CN21203218, CN21203219, CN21203220, CN21203221, CN21203232, CN21203233, CN21203234, CN21203235, CN21203236, CN21203237, CN21203238, CN21203239, CN21203240, CN21203241, CN21203242, CN21203243, CN21203244, CN21203245, CN21203246, CN21203247, CN21203248, CN21203249, CN21203250, CN21203251, CN21203252, CN21203290, CN21203291, CN21203292, CN21203293, CN21203294, CN21203295, CN21203296, CN21203297, CN21203323, CN21203324, CN21203337, CN21203338, CN21203339, CN21203363, CN21203383, CN21203384, CN21203385, CN21203386, CN21203387, CN21203393, CN21203394, CN21203395, CN21203396, CN21203397, CN21203404, CN21203405, CN21203406, CN21203407, CN21203408, CN21203409, CN21203410, CN21203411, CN21203412, CN21203413, CN21203414, CN21203417, CN21203462, CN21203463, CN21203464, CN21203465, CN21203466, CN21203467, CN21203636, CN21203709, CN21203710, CN21203711, CN21203712, CN21203741, CN21203750, CN21203751, CN21203752, CN21203753, CN21203829, CN21203830, CN21203831, CN21203832, CN21203833, CN21203834, CN21203835, CN21203836, CN21203837, CN21203838, CN21203871, CN21203872, CN21203873, CN21203874, CN21203875, CN21203876, CN21203877, CN21203878, CN21203879, CN21203880, CN21203881, CN21203882, CN21203883, CN21203884, CN21203885, CN21203900, CN21203901, CN21203902, CN21203903, CN21203904, CN21203905, CN21203906, CN21203907, CN21203908, CN21203909, CN21203910, CN21203911, CN21203912, CN21203913, CN21203914, CN21203915, CN21203916, CN21203917, CN21203918, CN21203919, CN21203920, CN21203921, CN21203922, CN21203923, CN21203954, CN21203955, CN21203956, CN21203957, CN21203958, CN21203962, CN21203963, CN21203964, CN21203971, CN21203972, CN21203973, CN21203974, CN21203975, CN21203976, CN21203977, CN21203978, CN21203979, CN21203980, CN21203981, CN21203982, CN21203983, CN21203984, CN21203995, CN21203996, CN21203997, CN21203998, CN21204006, CN21204012, CN21204014, CN21204015, CN21204123, CN21204124, CN21204212, CN21204213, CN21204216, CN21204217, CN21204275, CN21204276, CN21204277, CN21204278, CN21204279, CN21204280, CN21204281, CN21204282, CN21204316, CN21204326, CN21204327, CN21204328, CN21204373, CN21204374, USPP3NCK10
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Debra Levasseur
978-659-4065
Manufacturer Reason
for Recall
VS2+ screen may lock up and stop monitoring during patient use
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips issued an Urgent Medical Device Correction letter on January 14, 2013. The field action will take place in two phases: Phase 1 Philips sent customer an Urgent Medical Device Correction Notification/Field Safety Notice. This notification explains the issues and gives the customers instructions on actions to take while they await the hardware correction. Phase 2 Once the hardware correction Philips will contact customers and perform the correction free of charge. Until the correction is available. Affected products may continue to be used while waiting for the correction from Philips if the unit is not used in NBP interval mode. A Philips Healthcare representative will contact you to arrange for the correction of all affected devices. If you need any further information or support concerning this issue, please contact the Philips Customer Care Center at 1-800-722-9377. On 3/14/13, firm stated Initially the fix would be a hardware upgrade but have since changed that to a software update. Customers within the US will be sent a new Field Safety Notice as well as a USB software update package and will be required to notify us upon the upgrade of their affected units. They will be performing the updates themselves.
Quantity in Commerce 3248 units
Distribution 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = PHILIPS MEDICAL SYSTEMS
-
-