Class 2 Device Recall Spacelabs Healthcare XPREZZON Bedside Monitor

• Date Initiated by Firm: January 28, 2015
• Date Posted: February 24, 2015
• Recall Status: Terminated on December 30, 2015
• Recall Number: Z-1144-2015
• Recall Event ID: 70453
• 510(K)Number: K112962
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: 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.
• Code Information: 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, 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• FEI Number: 3010157426
• Recalling Firm/ Manufacturer: Spacelabs Healthcare Inc; 35301 SE Center St; Snoqualmie WA 98065-9216
• For Additional Information Contact: Technical Support; 800-522-7025 Ext. 2
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: total 1578 units (702 units in the US and 876 outside US)
• Distribution: Worldwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MHX