CLASS II Device recall · Reported 4 Mar 2015 · FDA Enforcement Report
Xprezzon Bedside Monitor recalled by Spacelabs Healthcare
Spacelabs Healthcare is recalling Spacelabs Healthcare Xprezzon Bedside Monitor. The recall was initiated on 28 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1144-2015
- FDA event ID
- 70453
- Recalling firm
- Spacelabs Healthcare, Snoqualmie, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2015
- FDA classified
- 24 Feb 2015
- Reported
- 4 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Patient Monitors
Timeline
| 28 Jan 2015 | Recall initiated by company | |
| 24 Feb 2015 | Classified by FDA | +27 days |
| 4 Mar 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Is Xprezzon Bedside Monitor recalled?
Yes. Spacelabs Healthcare recalled Xprezzon Bedside Monitor on 28 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1144-2015.
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Spacelabs Healthcare
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Xhibit Central Station recalled by Spacelabs Healthcare | Spacelabs Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Spacelabs Ultraview SL Command Module SL Command Module recalled | Spacelabs Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Multi-parameter Command Module recalled by Spacelabs Healthcare | Spacelabs Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Sentinel V11 recalled by Spacelabs Healthcare | Spacelabs Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Branding is not applied to this product DVI display cables recalled | Spacelabs Healthcare | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |