Device Recall Expression MRI Patient Monitoring System 의 리콜

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

Cardiovascular Devices

2

No

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.

Invivo Expression MRI Patient Monitoring System.