Philips Electronics North America Corporation: Medical Device Recall in 2015 - (Recall #: Z-2266-2015)

Invivo Expression MRI Patient Monitoring System.

Class II

The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esophageal.

Model Number 865214 (Invivo Expression MRI Patient Monitoring System) Devices with the FlexTEMP reusable temperature option installed (serial number range US31204918 through US42708744). Please note that not every serial number within the listed range has the temperature option. Devices without the temperature option are not affected by this Medical Device Correction. Serial Numbers: US31204918, US31204919, US31204920, US31204924, US31204925, US31204926, US31204927, US31204928, US31204929, US31204930, US31204931, US31204933, US31204935, US31204943, US31204944, US31204945, US31204946, US31204950, US31204951, US31204952, US31204956, US31204959, US31204960, US31204962, US31204963, US31204964, US31204965, US31204966, US31204967, US31204970, US31204971, US31204972, US31205010, US31205029, US31205030, US31205037, US31205038, US31205054, US31205074, US31205075, US31205076, US31205078, US31205081, US31205082, US31205083, US31205089, US31205090, US31205091, US31205092, US31205106, US31205107, US31205108, US31205109, US31205141, US31205142, US31205143, US31205148, US31205180, US31205208, US31205209, US31205228, US31205229, US31205230, US31205232, US31205273, US31205274, US31205275, US31205276, US31205277, US31205278, US31205279, US31205282, US31205285, US31205286, US31205287, US31205300, US31205301, US31205314, US31205315, US31205317, US31205318, US31205334, US31205341, US31205345, US31205392, US31205393, US31205398, US31205401, US31205402, US31205414, US31205426, US31205427, US31205428, US31205435, US31205436, US31205437, US31205438, US31205459, US31205460, US31205461, US31205462, US31205464, US31205473, US31205509, US31205510, US31205512, US31205518, US31205524, US31205526, US31205568, US31205569, US31205570, US31205571, US31205579, US31205581, US31205582, US31205583, US31205607, US31205611, US31205618, US31205619, US31205623, US31205624, US31205625, US31205627, US31205654, US31205655, US31205656, US31205657, US31205658, US31205667, US31205704, US31205712, US31205713, US31205715, US31205726, US31205727, US31205728, US31205729, US31205730, US31205731, US31205732, US31205733, US31205734, US31205735, US31205802, US31205803, US31205804, US31205805, US31205848, US31205850, US31205851, US31205853, US31205879, US31205909, US31205910, US31205911, US31205912, US31205913, US31205914, US31205915, US31205916, US31205938, US31205939, US31205940, US31205941, US31205971, US31205972, US31205978, US31205979, US31205992, US31205993, US31206022, US31206023, US31206027, US31206062, US31206063, US31206064, US31206065, US31206098, US31206099, US31206100, US31206101, US31206120, US31206121, US31206122, US31206123, US31206130, US31206132, US31206133, US31206134, US31206135, US31206141, US31206142, US31206143, US31206167, US31206172, US31206173, US31206175, US31206176, US31206177, US31206178, US31206179, US31206180, US31206197, US31206198, US31206199, US31206203, US31206222, US31206228, US31206234, US31206235, US31206236, US31206237, US31206238, US31206241, US31206242, US31206247, US31206248, US31206249, US31206250, US31206304, US31206305, US31206306, US31206319, US31206324, US31206328, US31206329, US31206347, US31206357, US31206358, US31206359, US31206360, US31206361, US31206362, US31206390, US31206391, US31206392, US31206397, US31206398, US31206399, US31206400, US31206401, US31206415, US31206420, US31206421, US31206422, US31206423, US31206424, US31206446, US31206447, US31206458, US31206459, US31206460, US31206461, US31206465, US31206466, US31206467, US31206483, US31206484, US31206485, US31206486, US31206487, US31206488, US31206491, US31206503, US31206504, US31206505, US31206508, US31206509, US31206525, US31206533, US31206534, US31206535, US31206536, US31206539, US31206540, US31206541, US31206575, US31206590, US31206594, US31206595, US31206596, US31206597, US31206598, US31206626, US31206633, US31206634, US31206635, US31206636, US31206637, US31206638, US31206639, US31206640, US31206641, US31206642, US31206643, US31206668, US31206670, US31206671, US31206672, US31206673, US31206674, US31206675, US31206676, US31206677, US31206678, US31206679, US31206680, US31206681, US31206682, US31206683, US31206684, US31206685, US31206686, US31206689, US31206690, US31206691, US31206725, US31206726, US31206769, US31206770, US31206780, US31206781, US31206782, US31206783, US31206784, US31206785, US31206786, US31206787, US31206788, US31206789, US31206792, US31206807, US31206808, US31206809, US31206810, US31206826, US31206827, US31206828, US31206829, US31206830, US31206831, US31206832, US31206833, US31206860, US31206861, US31206863, US31206875, US31206876, US31206877, US42706956, US42706957, US42706968, US42706969, US42706972, US42706973, US42706989, US42706990, US42706994, US42707026, US42707027, US42707028, US42707029, US42707030, US42707031, US42707034, US42707035, US42707036, US42707038, US42707065, US42707071, US42707072, US42707073, US42707074, US42707075, US42707085, US42707150, US42707151, US42707152, US42707153, US42707154, US42707155, US42707156, US42707161, US42707162, US42707163, US42707164, US42707165, US42707166, US42707167, US42707168, US42707189, US42707190, US42707191, US42707192, US42707193, US42707194, US42707195, US42707196, US42707199, US42707200, US42707228, US42707229, US42707230, US42707231, US42707232, US42707233, US42707234, US42707235, US42707375, US42707379, US42707380, US42707381, US42707382, US42707383, US42707384, US42707385, US42707386, US42707387, US42707388, US42707389, US42707390, US42707391, US42707392, US42707393, US42707394, US42707395, US42707396, US42707397, US42707398, US42707399, US42707400, US42707401, US42707402, US42707403, US42707419, US42707420, US42707421, US42707422, US42707423, US42707424, US42707425, US42707426, US42707427, US42707428, US42707429, US42707430, US42707431, US42707432, US42707493, US42707514, US42707515, US42707516, US42707517, US42707518, US42707519, US42707520, US42707521, US42707522, US42707523, US42707524, US42707526, US42707527, US42707528, US42707529, US42707531, US42707541, US42707568, US42707569, US42707570, US42707571, US42707572, US42707579, US42707580, US42707581, US42707584, US42707592, US42707593, US42707609, US42707611, US42707612, US42707617, US42707618, US42707619, US42707620, US42707622, US42707627, US42707628, US42707658, US42707660, US42707669, US42707670, US42707671, US42707672, US42707673, US42707674, US42707675, US42707683, US42707705, US42707706, US42707707, US42707708, US42707734, US42707735, US42707742, US42707753, US42707778, US42707781, US42707782, US42707783, US42707786, US42707787, US42707811, US42707812, US42707817, US42707818, US42707819, US42707820, US42707821, US42707843, US42707844, US42707852, US42707853, US42707854, US42707856, US42707857, US42707858, US42707859, US42707888, US42707889, US42707890, US42707891, US42707892, US42707893, US42707894, US42707899, US42707909, US42707912, US42707931, US42707932, US42707942, US42707943, US42707963, US42707964, US42707965, US42708004, US42708005, US42708006, US42708007, US42708011, US42708020, US42708023, US42708024, US42708045, US42708046, US42708047, US42708048, US42708049, US42708055, US42708056, US42708057, US42708058, US42708059, US42708060, US42708061, US42708067, US42708068, US42708069, US42708070, US42708071, US42708074, US42708077, US42708078, US42708079, US42708120, US42708121, US42708122, US42708137, US42708138, US42708139, US42708140, US42708141, US42708163, US42708164, US42708219, US42708220, US42708221, US42708222, US42708234, US42708235, US42708236, US42708244, US42708245, US42708255, US42708256, US42708257, US42708275, US42708277, US42708278, US42708279, US42708280, US42708281, US42708282, US42708302, US42708303, US42708304, US42708305, US42708306, US42708328, US42708331, US42708332, US42708333, US42708334, US42708335, US42708336, US42708368, US42708370, US42708371, US42708372, US42708373, US42708374, US42708384, US42708385, US42708386, US42708387, US42708388, US42708389, US42708391, US42708392, US42708417, US42708418, US42708420, US42708421, US42708423, US42708424, US42708430, US42708456, US42708457, US42708458, US42708459, US42708460, US42708461, US42708462, US42708463, US42708464, US42708465, US42708468, US42708469, US42708470, US42708471, US42708486, and US42708487

Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OR, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Alaska, Hawaii and the District of Columbia, and the countries of Argentina, Australia, Austria, Canada, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, Iceland, Israel, Italy, Japan, Netherlands, Norway, Oman, Poland, Portugal, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, United Arab Emirates, and United Kingdom.

Voluntary: Firm initiated