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Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393.… recallZ-1144-2015 · Spacelabs Healthcare Inc · initiated Jan 28, 2015

Class II Terminated All recalls posted in February 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Spacelabs Healthcare Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1144-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 28, 2015
Posted by the FDA
Feb 24, 2015
Recalling firm
Spacelabs Healthcare Inc
Quantity
total 1578 units (702 units in the US and 876 outside US)
Product code
MHX
FDA submissions
K112962
Distribution
Worldwide Distribution.

Product description

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 (models, lots, serial numbers)

Show the full code information (21k characters)

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.

Other devices under the same FDA submission

2 devices cleared under K112962 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 70453).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page