Retiro De Equipo (Recall) de Device Recall Spacelabs Healthcare XPREZZON Bedside Monitor

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Spacelabs Healthcare Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    70453
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1144-2015
  • Fecha de inicio del evento
    2015-01-28
  • Fecha de publicación del evento
    2015-02-24
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2015-12-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    Spacelabs healthcare xprezzon bedside monitors, model 91393, are recalled because the firm has received multiple reports of xprezzon monitors failing to boot up or returning to factory default configuration settings following power on or reset.
  • Acción
    Spacelabs began to send the Urgent Medical Device Correction XPREZZON Bedside Monitor, Model 91393 qube Compact Monitor, Model 91390 letter, dated 28, January 2015, to US consignees. Spacelabs began sending the Urgent Medical Device Correction XPREZZON Bedside Monitor, Model 91393 qube Compact Monitor, Model 91390 letter (translated as necessary) to international customers via email on 2/4/15. Actions to be Implemented by Users: -Do not rely solely on the monitor for critically ill patients. -If customer facility operates any XPREZZON or qube monitors on a standalone basis, rather than via central monitoring, please contact Spacelabs technical support as these monitors will be the first repaired. Spacelabs Healthcare will contact consignees to schedule a convenient time for Spacelabs to replace the PCBAs in all of your facility's affected XPREZZON and qube monitors at no cost. If you have any questions about this corrective action, please contact Spacelabs at the toll free number of 1-800-522-7025 and select 2 for Technical Support, or via direct dial at 1-425-363-5203.

Device

  • Modelo / Serial
    SERIAL NUMBERS OF UNITS IN THE US:  1390-000197, 1393-000024, 1393-000166, 1393-000199, 1393-003451, 1393-003970, 1393-004222, 1393-004306, 1393-004319, 1393-004457, 1393-004962, 1393-005365, 1393-006156, 1393-006635, 1393-006636, 1393-006815, 1393-006816, 1393-006839, 1393-006840, 1393-006841, 1393-006842, 1393-006844, 1393-006845, 1393-006846, 1393-006847, 1393-006976, 1393-006977, 1393-006978, 1393-006979, 1393-006980, 1393-006981, 1393-006982, 1393-006983, 1393-006984, 1393-006985, 1393-006986, 1393-006987, 1393-007017, 1393-007020, 1393-007021, 1393-007022, 1393-007024, 1393-007025, 1393-007026, 1393-007027, 1393-007028, 1393-007029, 1393-007030, 1393-007031, 1393-007032, 1393-007033, 1393-007034, 1393-007035, 1393-007036, 1393-007037, 1393-007038, 1393-007039, 1393-007040, 1393-007041, 1393-007042, 1393-007043, 1393-007044, 1393-007045, 1393-007046, 1393-007047, 1393-007048, 1393-007049, 1393-007050, 1393-007051, 1393-007052, 1393-007053, 1393-007054, 1393-007055, 1393-007056, 1393-007057, 1393-007058, 1393-007059, 1393-007060, 1393-007061, 1393-007064, 1393-007065, 1393-007066, 1393-007067, 1393-007068, 1393-007069, 1393-007070, 1393-007071, 1393-007072, 1393-007073, 1393-007074, 1393-007161, 1393-007295, 1393-007296, 1393-007297, 1393-007298, 1393-007299, 1393-007300, 1393-007301, 1393-007302, 1393-007303, 1393-007304, 1393-007305, 1393-007306, 1393-007307, 1393-007308, 1393-007311, 1393-007312, 1393-007313, 1393-007315, 1393-007316, 1393-007317, 1393-007318, 1393-007319, 1393-007320, 1393-007321, 1393-007322, 1393-007323, 1393-007324, 1393-007338, 1393-007339, 1393-007341, 1393-007342, 1393-100036, 1393-100037, 1393-100038, 1393-100039, 1393-100040, 1393-100043, 1393-100045, 1393-100054, 1393-100059, 1393-100068, 1393-100073, 1393-100098, 1393-100102, 1393-100103, 1393-100104, 1393-100105, 1393-100106, 1393-100107, 1393-100108, 1393-100109, 1393-100110, 1393-100120, 1393-100121, 1393-100122, 1393-100123, 1393-100124, 1393-100125, 1393-100126, 1393-100127, 1393-100128, 1393-100129, 1393-100130, 1393-100131, 1393-100132, 1393-100133, 1393-100134, 1393-100137, 1393-100138, 1393-100139, 1393-100140, 1393-100141, 1393-100142, 1393-100143, 1393-100144, 1393-100145, 1393-100146, 1393-100147, 1393-100148, 1393-100149, 1393-100151, 1393-100152, 1393-100153, 1393-100154, 1393-100155, 1393-100156, 1393-100157, 1393-100158, 1393-100159, 1393-100160, 1393-100161, 1393-100162, 1393-100163, 1393-100164, 1393-100165, 1393-100166, 1393-100167, 1393-100168, 1393-100169, 1393-100170, 1393-100171, 1393-100172, 1393-100173, 1393-100174, 1393-100175, 1393-100176, 1393-100177, 1393-100178, 1393-100179, 1393-100180, 1393-100181, 1393-100182, 1393-100183, 1393-100184, 1393-100185, 1393-100186, 1393-100187, 1393-100188, 1393-100189, 1393-100190, 1393-100191, 1393-100192, 1393-100193, 1393-100194, 1393-100195, 1393-100197, 1393-100198, 1393-100199, 1393-100200, 1393-100201, 1393-100202, 1393-100203, 1393-100204, 1393-100205, 1393-100206, 1393-100207, 1393-100208, 1393-100209, 1393-100210, 1393-100214, 1393-100271, 1393-100272, 1393-100274, 1393-100277, 1393-100278, 1393-100279, 1393-100280, 1393-100281, 1393-100282, 1393-100283, 1393-100284, 1393-100285, 1393-100286, 1393-100298, 1393-100299, 1393-100302, 1393-100320, 1393-100334, 1393-100336, 1393-100337, 1393-100340, 1393-100374, 1393-100388, 1393-100389, 1393-100390, 1393-100391, 1393-100392, 1393-100393, 1393-100394, 1393-100395, 1393-100396, 1393-100397, 1393-100398, 1393-100399, 1393-100400, 1393-100401, 1393-100460, 1393-100461, 1393-100462, 1393-100473, 1393-100550, 1393-100551, 1393-100552, 1393-100553, 1393-100554, 1393-100555, 1393-100556, 1393-100557, 1393-100558, 1393-100559, 1393-100560, 1393-100561, 1393-100562, 1393-100563, 1393-100564, 1393-100565, 1393-100566, 1393-100567, 1393-100571, 1393-100572, 1393-100573, 1393-100574, 1393-100575, 1393-100576, 1393-100577, 1393-100578, 1393-100579, 1393-100580, 1393-100581, 1393-100582, 1393-100583, 1393-100584, 1393-100585, 1393-100586, 1393-100587, 1393-100588, 1393-100589, 1393-100590, 1393-100591, 1393-100592, 1393-100593, 1393-100594, 1393-100595, 1393-100596, 1393-100597, 1393-100598, 1393-100599, 1393-100600, 1393-100601, 1393-100602, 1393-100603, 1393-100604, 1393-100605, 1393-100606, 1393-100607, 1393-100608, 1393-100609, 1393-100610, 1393-100611, 1393-100612, 1393-100613, 1393-100614, 1393-100615, 1393-100616, 1393-100617, 1393-100618, 1393-100619, 1393-100620, 1393-100621, 1393-100622, 1393-100623, 1393-100624, 1393-100625, 1393-100626, 1393-100627, 1393-100628, 1393-100629, 1393-100630, 1393-100631, 1393-100632, 1393-100633, 1393-100634, 1393-100635, 1393-100636, 1393-100637, 1393-100638, 1393-100640, 1393-100641, 1393-100642, 1393-100643, 1393-100644, 1393-100645, 1393-100646, 1393-100647, 1393-100648, 1393-100649, 1393-100650, 1393-100651, 1393-100652, 1393-100653, 1393-100654, 1393-100655, 1393-100656, 1393-100657, 1393-100658, 1393-100659, 1393-100660, 1393-100661, 1393-100662, 1393-100663, 1393-100664, 1393-100665, 1393-100666, 1393-100667, 1393-100668, 1393-100669, 1393-100670, 1393-100671, 1393-100672, 1393-100673, 1393-100674, 1393-100675, 1393-100676, 1393-100677, 1393-100678, 1393-100679, 1393-100680, 1393-100681, 1393-100682, 1393-100683, 1393-100684, 1393-100685, 1393-100686, 1393-100687, 1393-100688, 1393-100689, 1393-100690, 1393-100691, 1393-100692, 1393-100693, 1393-100694, 1393-100695, 1393-100696, 1393-100697, 1393-100698, 1393-100699, 1393-100700, 1393-100701, 1393-100702, 1393-100703, 1393-100704, 1393-100705, 1393-100706, 1393-100707, 1393-100708, 1393-100709, 1393-100710, 1393-100711, 1393-100712, 1393-100713, 1393-100714, 1393-100715, 1393-100716, 1393-100717, 1393-100752, 1393-100753, 1393-100776, 1393-100777, 1393-100778, 1393-100779, 1393-100780, 1393-100781, 1393-100782, 1393-100783, 1393-100784, 1393-100785, 1393-100786, 1393-100787, 1393-100809, 1393-100810, 1393-100815, 1393-100816, 1393-100818, 1393-100822, 1393-100854, 1393-100855, 1393-100960, 1393-100961, 1393-100962, 1393-100963, 1393-100964, 1393-100966, 1393-100971, 1393-100972, 1393-100974, 1393-100976, 1393-100977, 1393-100978, 1393-100979, 1393-100980, 1393-100981, 1393-100982, 1393-100983, 1393-100984, 1393-100985, 1393-100992, 1393-100993, 1393-100994, 1393-100995, 1393-100996, 1393-100998, 1393-100999, 1393-101000, 1393-101003, 1393-101021, 1393-101024, 1393-101026, 1393-101028, 1393-101040, 1393-101041, 1393-101046, 1393-101047, 1393-101048, 1393-101049, 1393-101050, 1393-101051, 1393-101052, 1393-101053, 1393-101054, 1393-101055, 1393-101056, 1393-101057, 1393-101058, 1393-101059, 1393-101060, 1393-101061, 1393-101062, 1393-101063, 1393-101064, 1393-101065, 1393-101066, 1393-101067, 1393-101068, 1393-101069, 1393-101070, 1393-101071, 1393-101072, 1393-101073, 1393-101074, 1393-101075, 1393-101076, 1393-101077, 1393-101078, 1393-101079, 1393-101080, 1393-101081, 1393-101082, 1393-101083, 1393-101091, 1393-101092, 1393-101093, 1393-101094, 1393-101102, 1393-101103, 1393-101111, 1393-101112, 1393-101117, 1393-101120, 1393-101121, 1393-101122, 1393-101123, 1393-101124, 1393-101125, 1393-101126, 1393-101127, 1393-101128, 1393-101129, 1393-101130, 1393-101131, 1393-101132, 1393-101133, 1393-101134, 1393-101135, 1393-101136, 1393-101137, 1393-101138, 1393-101145, 1393-101146, 1393-101147, 1393-101148, 1393-101149, 1393-101150, 1393-101151, 1393-101152, 1393-101153, 1393-101154, 1393-101155, 1393-101156, 1393-101157, 1393-101158, 1393-101159, 1393-101160, 1393-101161, 1393-101162, 1393-101163, 1393-101164, 1393-101169, 1393-101170, 1393-101171, 1393-101172, 1393-101173, 1393-101207, 1393-101208, 1393-101239, 1393-101269, 1393-101270, 1393-101271, 1393-101272, 1393-101273, 1393-101274, 1393-101275, 1393-101276, 1393-101277, 1393-101278, 1393-101279, 1393-101280, 1393-101281, 1393-101282, 1393-101283, 1393-101284, 1393-101285, 1393-101286, 1393-101287, 1393-101288, 1393-101289, 1393-101290, 1393-101291, 1393-101292, 1393-101293, 1393-101294, 1393-101295, 1393-101296, 1393-101297, 1393-101298, 1393-101299, 1393-101300, 1393-101301, 1393-101302, 1393-101303, 1393-101336, 1393-101338, 1393-101339, 1393-101340, 1393-101341, 1393-101342, 1393-101343, 1393-101344, 1393-101345, 1393-101346, 1393-101347, 1393-101348, 1393-101349, 1393-101350, 1393-101351, 1393-101352, 1393-101353, 1393-101354, 1393-101355, 1393-101356, 1393-101361, 1393-101362, 1393-101363, 1393-101380, 1393-101381, 1393-101389, 1393-101390, 1393-101391, 1393-101392, 1393-101393, 1393-101394, 1393-101395, 1393-101396, 1393-101397, 1393-101398, 1393-101399, 1393-101400, 1393-101405, 1393-101406, 1393-101407, 1393-101408, 1393-101409, 1393-101410, 1393-101411, 1393-101412, 1393-101413, 1393-101414, 1393-101415, 1393-101416, 1393-101417, 1393-101418, 1393-101419, 1393-101420, 1393-101421, 1393-101422, 1393-101423, 1393-101424, 1393-101425, 1393-101426, 1393-101427, 1393-101428, 1393-101429, 1393-101430, 1393-101431, 1393-101432, 1393-101433, 1393-101434, 1393-101435, 1393-101436, 1393-101437, 1393-101438, 1393-101439, 1393-101440, 1393-101441, 1393-101442, 1393-101443, 1393-101444, 1393-101445, 1393-101446, 1393-101447, 1393-101448, 1393-101454.   SERIAL NUMBERS OF UNITS OUTSIDE THE US:  1393-000011, 1393-000162, 1393-000172, 1393-000235, 1393-000236, 1393-000237, 1393-000238, 1393-000239, 1393-000240, 1393-000241, 1393-000335, 1393-000346, 1393-000347, 1393-000348, 1393-000349, 1393-000350, 1393-000351, 1393-000352, 1393-000353, 1393-000354, 1393-000355, 1393-001060, 1393-001066, 1393-003146, 1393-003148, 1393-004028, 1393-004427, 1393-004965, 1393-004972, 1393-004973, 1393-004982, 1393-005510, 1393-006963, 1393-006964, 1393-006965, 1393-006966, 1393-006967, 1393-006968, 1393-007018, 1393-007019, 1393-007062, 1393-007063, 1393-007153, 1393-007154, 1393-007155, 1393-007156, 1393-007157, 1393-007158, 1393-007159, 1393-007160, 1393-007290, 1393-007291, 1393-007292, 1393-007293, 1393-007294, 1393-007325, 1393-007326, 1393-007327, 1393-007328, 1393-007329, 1393-007330, 1393-007331, 1393-007332, 1393-007333, 1393-007334, 1393-007335, 1393-007336, 1393-007337, 1393-007340, 1393-100021, 1393-100022, 1393-100023, 1393-100024, 1393-100025, 1393-100026, 1393-100027, 1393-100028, 1393-100029, 1393-100030, 1393-100031, 1393-100032, 1393-100033, 1393-100035, 1393-100041, 1393-100042, 1393-100044, 1393-100046, 1393-100047, 1393-100048, 1393-100049, 1393-100050, 1393-100051, 1393-100052, 1393-100053, 1393-100055, 1393-100057, 1393-100058, 1393-100060, 1393-100061, 1393-100062, 1393-100063, 1393-100064, 1393-100065, 1393-100066, 1393-100067, 1393-100069, 1393-100070, 1393-100071, 1393-100072, 1393-100074, 1393-100075, 1393-100076, 1393-100077, 1393-100078, 1393-100079, 1393-100080, 1393-100081, 1393-100082, 1393-100083, 1393-100084, 1393-100085, 1393-100086, 1393-100087, 1393-100088, 1393-100089, 1393-100090, 1393-100091, 1393-100092, 1393-100093, 1393-100094, 1393-100095, 1393-100096, 1393-100097, 1393-100099, 1393-100100, 1393-100101, 1393-100111, 1393-100112, 1393-100113, 1393-100114, 1393-100115, 1393-100116, 1393-100118, 1393-100119, 1393-100211, 1393-100212, 1393-100213, 1393-100215, 1393-100216, 1393-100217, 1393-100218, 1393-100219, 1393-100220, 1393-100221, 1393-100223, 1393-100224, 1393-100225, 1393-100226, 1393-100227, 1393-100228, 1393-100229, 1393-100230, 1393-100231, 1393-100232, 1393-100233, 1393-100234, 1393-100235, 1393-100236, 1393-100237, 1393-100238, 1393-100239, 1393-100240, 1393-100241, 1393-100242, 1393-100243, 1393-100244, 1393-100245, 1393-100246, 1393-100247, 1393-100248, 1393-100250, 1393-100251, 1393-100252, 1393-100253, 1393-100254, 1393-100255, 1393-100256, 1393-100257, 1393-100258, 1393-100259, 1393-100260, 1393-100261, 1393-100262, 1393-100263, 1393-100264, 1393-100265, 1393-100266, 1393-100267, 1393-100268, 1393-100269, 1393-100270, 1393-100273, 1393-100275, 1393-100276, 1393-100287, 1393-100288, 1393-100289, 1393-100290, 1393-100291, 1393-100292, 1393-100293, 1393-100294, 1393-100295, 1393-100296, 1393-100297, 1393-100300, 1393-100301, 1393-100305, 1393-100306, 1393-100307, 1393-100308, 1393-100309, 1393-100310, 1393-100311, 1393-100312, 1393-100313, 1393-100314, 1393-100315, 1393-100317, 1393-100318, 1393-100319, 1393-100321, 1393-100322, 1393-100323, 1393-100324, 1393-100325, 1393-100326, 1393-100327, 1393-100328, 1393-100329, 1393-100330, 1393-100331, 1393-100332, 1393-100333, 1393-100335, 1393-100338, 1393-100339, 1393-100341, 1393-100342, 1393-100343, 1393-100344, 1393-100345, 1393-100346, 1393-100347, 1393-100348, 1393-100349, 1393-100350, 1393-100351, 1393-100352, 1393-100353, 1393-100354, 1393-100355, 1393-100356, 1393-100357, 1393-100358, 1393-100359, 1393-100360, 1393-100361, 1393-100362, 1393-100363, 1393-100364, 1393-100365, 1393-100366, 1393-100367, 1393-100368, 1393-100369, 1393-100370, 1393-100371, 1393-100372, 1393-100373, 1393-100375, 1393-100376, 1393-100377, 1393-100378, 1393-100379, 1393-100380, 1393-100381, 1393-100382, 1393-100383, 1393-100384, 1393-100385, 1393-100386, 1393-100387, 1393-100402, 1393-100403, 1393-100404, 1393-100405, 1393-100406, 1393-100407, 1393-100408, 1393-100409, 1393-100410, 1393-100411, 1393-100412, 1393-100413, 1393-100414, 1393-100415, 1393-100416, 1393-100417, 1393-100418, 1393-100419, 1393-100420, 1393-100421, 1393-100422, 1393-100423, 1393-100424, 1393-100425, 1393-100426, 1393-100427, 1393-100428, 1393-100429, 1393-100430, 1393-100431, 1393-100432, 1393-100433, 1393-100434, 1393-100435, 1393-100436, 1393-100437, 1393-100438, 1393-100439, 1393-100440, 1393-100442, 1393-100443, 1393-100444, 1393-100445, 1393-100446, 1393-100447, 1393-100448, 1393-100449, 1393-100450, 1393-100451, 1393-100452, 1393-100453, 1393-100454, 1393-100455, 1393-100456, 1393-100457, 1393-100458, 1393-100459, 1393-100464, 1393-100465, 1393-100466, 1393-100467, 1393-100468, 1393-100474, 1393-100475, 1393-100476, 1393-100477, 1393-100478, 1393-100479, 1393-100480, 1393-100481, 1393-100482, 1393-100483, 1393-100484, 1393-100485, 1393-100486, 1393-100487, 1393-100488, 1393-100489, 1393-100490, 1393-100491, 1393-100492, 1393-100493, 1393-100494, 1393-100495, 1393-100496, 1393-100497, 1393-100498, 1393-100499, 1393-100500, 1393-100501, 1393-100502, 1393-100503, 1393-100504, 1393-100505, 1393-100506, 1393-100507, 1393-100508, 1393-100509, 1393-100510, 1393-100511, 1393-100512, 1393-100513, 1393-100514, 1393-100515, 1393-100516, 1393-100517, 1393-100518, 1393-100519, 1393-100520, 1393-100521, 1393-100522, 1393-100523, 1393-100524, 1393-100525, 1393-100526, 1393-100527, 1393-100528, 1393-100529, 1393-100530, 1393-100531, 1393-100532, 1393-100533, 1393-100534, 1393-100535, 1393-100536, 1393-100537, 1393-100538, 1393-100539, 1393-100540, 1393-100541, 1393-100542, 1393-100543, 1393-100544, 1393-100545, 1393-100546, 1393-100547, 1393-100548, 1393-100549, 1393-100568, 1393-100569, 1393-100570, 1393-100639, 1393-100718, 1393-100719, 1393-100720, 1393-100721, 1393-100722, 1393-100723, 1393-100724, 1393-100725, 1393-100726, 1393-100727, 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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA