Philips Electronics North America Corporation: Invivo Expression MRI Patient Monitoring System.

Recall number

Z-2266-2015

Recalling firm

Philips Electronics North America Corporation

Product

Invivo Expression MRI Patient Monitoring System.

Status

Terminated

Initiated

2015-06-17

Posted

2015-07-27

Terminated

2019-10-02

Reason

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.

Root 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

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.

Lot, serial or model codes

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

510(k) numbers

["K124061"]

PMA numbers

not on file

Product code

MWI

Firm FEI

1218950

Firm city

Andover

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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