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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71541

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 17, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Invivo Expression MRI Patient Monitoring System.

Z-2266-2015
Recall number
Z-2266-2015
Initiated
June 17, 2015
Classification
Class II
Status
Terminated
Quantity
697 devices.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

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.