Class 2 Device Recall Expression MRI Patient Monitoring System

• Date Initiated by Firm: June 17, 2015
• Date Posted: July 27, 2015
• Recall Status: Terminated on October 02, 2019
• Recall Number: Z-2266-2015
• Recall Event ID: 71541
• 510(K)Number: K124061
• Product Classification: Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
• Product: Invivo Expression MRI Patient Monitoring System.
• Code Information: 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
• Recalling Firm/ Manufacturer: Philips Electronics North America Corporation; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Philips Representative; 800-722-9377
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling False and Misleading
• Action: An URGENT Medical Device Correction was sent to all consignees by letter June 2015 regarding the Invivo Expression MRI Patient Monitoring System FlexTEMP Application Site explaining the reason for the affected labeling.
• Quantity in Commerce: 697 devices.
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MWI and Original Applicant = INVIVO CORPORATION