Spacelabs Healthcare Inc: 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.

Recall number

Z-1144-2015

Recalling firm

Spacelabs Healthcare Inc

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.

Status

Terminated

Initiated

2015-01-28

Posted

2015-02-24

Terminated

2015-12-30

Reason

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.

Root 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

total 1578 units (702 units in the US and 876 outside US)

Distribution

Worldwide Distribution.

Lot, serial or model codes

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, 1393-100728, 1393-100729, 1393-100730, 1393-100731, 1393-100732, 1393-100733, 1393-100734, 1393-100735, 1393-100736, 1393-100737, 1393-100738, 1393-100739, 1393-100740, 1393-100741, 1393-100742, 1393-100743, 1393-100744, 1393-100745, 1393-100746, 1393-100747, 1393-100748, 1393-100749, 1393-100750, 1393-100751, 1393-100754, 1393-100755, 1393-100756, 1393-100757, 1393-100758, 1393-100759, 1393-100760, 1393-100762, 1393-100763, 1393-100764, 1393-100765, 1393-100766, 1393-100767, 1393-100768, 1393-100769, 1393-100770, 1393-100771, 1393-100772, 1393-100773, 1393-100774, 1393-100775, 1393-100788, 1393-100789, 1393-100790, 1393-100791, 1393-100792, 1393-100793, 1393-100794, 1393-100795, 1393-100796, 1393-100797, 1393-100798, 1393-100799, 1393-100800, 1393-100801, 1393-100802, 1393-100803, 1393-100804, 1393-100805, 1393-100806, 1393-100807, 1393-100808, 1393-100811, 1393-100812, 1393-100813, 1393-100814, 1393-100817, 1393-100819, 1393-100820, 1393-100821, 1393-100823, 1393-100824, 1393-100825, 1393-100826, 1393-100827, 1393-100828, 1393-100829, 1393-100830, 1393-100831, 1393-100832, 1393-100833, 1393-100834, 1393-100835, 1393-100836, 1393-100837, 1393-100838, 1393-100839, 1393-100840, 1393-100841, 1393-100842, 1393-100843, 1393-100844, 1393-100845, 1393-100846, 1393-100847, 1393-100848, 1393-100849, 1393-100850, 1393-100851, 1393-100852, 1393-100853, 1393-100856, 1393-100857, 1393-100858, 1393-100859, 1393-100860, 1393-100861, 1393-100862, 1393-100863, 1393-100864, 1393-100865, 1393-100866, 1393-100867, 1393-100868, 1393-100869, 1393-100870, 1393-100871, 1393-100872, 1393-100873, 1393-100874, 1393-100875, 1393-100876, 1393-100877, 1393-100878, 1393-100879, 1393-100880, 1393-100881, 1393-100882, 1393-100883, 1393-100884, 1393-100885, 1393-100886, 1393-100887, 1393-100888, 1393-100889, 1393-100890, 1393-100891, 1393-100892, 1393-100893, 1393-100894, 1393-100895, 1393-100896, 1393-100897, 1393-100898, 1393-100899, 1393-100900, 1393-100901, 1393-100902, 1393-100903, 1393-100904, 1393-100905, 1393-100906, 1393-100907, 1393-100908, 1393-100909, 1393-100910, 1393-100911, 1393-100912, 1393-100913, 1393-100914, 1393-100915, 1393-100916, 1393-100917, 1393-100918, 1393-100919, 1393-100920, 1393-100921, 1393-100922, 1393-100923, 1393-100924, 1393-100925, 1393-100926, 1393-100927, 1393-100928, 1393-100929, 1393-100930, 1393-100931, 1393-100932, 1393-100933, 1393-100934, 1393-100935, 1393-100936, 1393-100937, 1393-100938, 1393-100939, 1393-100940, 1393-100941, 1393-100942, 1393-100943, 1393-100944, 1393-100945, 1393-100946, 1393-100947, 1393-100948, 1393-100949, 1393-100950, 1393-100951, 1393-100952, 1393-100953, 1393-100954, 1393-100955, 1393-100956, 1393-100957, 1393-100958, 1393-100959, 1393-100965, 1393-100967, 1393-100968, 1393-100969, 1393-100970, 1393-100973, 1393-100975, 1393-100986, 1393-100987, 1393-100988, 1393-100990, 1393-100991, 1393-100997, 1393-101001, 1393-101002, 1393-101004, 1393-101005, 1393-101006, 1393-101007, 1393-101008, 1393-101009, 1393-101010, 1393-101011, 1393-101012, 1393-101013, 1393-101014, 1393-101015, 1393-101016, 1393-101017, 1393-101018, 1393-101019, 1393-101020, 1393-101022, 1393-101023, 1393-101025, 1393-101027, 1393-101029, 1393-101030, 1393-101031, 1393-101032, 1393-101033, 1393-101034, 1393-101035, 1393-101036, 1393-101037, 1393-101038, 1393-101039, 1393-101042, 1393-101043, 1393-101044, 1393-101045, 1393-101084, 1393-101085, 1393-101086, 1393-101087, 1393-101088, 1393-101089, 1393-101090, 1393-101095, 1393-101096, 1393-101097, 1393-101098, 1393-101099, 1393-101100, 1393-101101, 1393-101104, 1393-101105, 1393-101106, 1393-101107, 1393-101108, 1393-101109, 1393-101110, 1393-101113, 1393-101114, 1393-101115, 1393-101116, 1393-101118, 1393-101119, 1393-101139, 1393-101140, 1393-101141, 1393-101142, 1393-101143, 1393-101165, 1393-101166, 1393-101167, 1393-101168, 1393-101174, 1393-101175, 1393-101176, 1393-101177, 1393-101178, 1393-101179, 1393-101180, 1393-101181, 1393-101182, 1393-101183, 1393-101184, 1393-101185, 1393-101186, 1393-101187, 1393-101188, 1393-101189, 1393-101190, 1393-101191, 1393-101192, 1393-101193, 1393-101194, 1393-101195, 1393-101196, 1393-101197, 1393-101198, 1393-101199, 1393-101200, 1393-101201, 1393-101202, 1393-101203, 1393-101204, 1393-101205, 1393-101206, 1393-101209, 1393-101210, 1393-101211, 1393-101212, 1393-101213, 1393-101214, 1393-101215, 1393-101216, 1393-101217, 1393-101218, 1393-101219, 1393-101220, 1393-101221, 1393-101222, 1393-101223, 1393-101224, 1393-101225, 1393-101226, 1393-101227, 1393-101228, 1393-101229, 1393-101230, 1393-101231, 1393-101232, 1393-101233, 1393-101234, 1393-101235, 1393-101236, 1393-101237, 1393-101238, 1393-101241, 1393-101242, 1393-101243, 1393-101244, 1393-101245, 1393-101246, 1393-101247, 1393-101248, 1393-101249, 1393-101250, 1393-101251, 1393-101252, 1393-101253, 1393-101254, 1393-101255, 1393-101256, 1393-101257, 1393-101258, 1393-101259, 1393-101260, 1393-101261, 1393-101262, 1393-101263, 1393-101264, 1393-101265, 1393-101266, 1393-101267, 1393-101268, 1393-101322, 1393-101323, 1393-101324, 1393-101325, 1393-101326, 1393-101327, 1393-101328, 1393-101329, 1393-101330, 1393-101331, 1393-101332, 1393-101333, 1393-101334, 1393-101335, 1393-101357, 1393-101358, 1393-101359, 1393-101360, 1393-101370, 1393-101371, 1393-101372, 1393-101373, 1393-101374, 1393-101375, 1393-101376, 1393-101377, 1393-101378, 1393-101379, 1393-101401, 1393-101402, 1393-101403, 1393-101404, 1393-101455, 1393-101456, 1393-101457, 1393-101458, 1393-101459, 1393-101460, 1393-101461, 1393-101462, 1393-101463, 1393-101464, 1393-101465, 1393-101466.

510(k) numbers

["K112962"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3010157426

Firm city

Snoqualmie

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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