Exact FDA event identifier

Event 96138

5 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 15, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Philips North America Llc

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

5 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 5

IntelliBridge EC10 Module. Model Number: 865115

Z-1106-2025

Recall number: Z-1106-2025
Initiated: January 15, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 2,230 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Code information

Model Number: 865115. UDI-DI Number: (01)00884838015951(21). Serial Numbers: DE57029003, DE57028993, DE57028976, DE57028982, DE57028983, DE57028987, DE57028988, DE57028951, DE57028992, DE57029001, DE57029002, DE57028989, DE57028990, DE57028991, DE57029000, DE61951169, DE61951170, DE61951171, DE61951143, DE61951141, DE61951139, DE61951172, DE61951173, DE61951193, DE61951096, DE70164542, DE70164538, DE70164539, DE70164540, DE70169842, DE70169843, DE70169846, DE70175669, DE57034208, DE57034005, DE57034248, DE57034244, DE57034243, DE57034241, DE57034237, DE57034234, DE57034231, DE57034261, DE57034245, DE57034238, DE57034229, DE57034220, DE57034030, DE57034188, DE57034679, DE57034671, DE73784113, DE73784325, DE73784414, DE73784137, DE70171598, DE70171596, DE70171601, DE70171602, DE70171597, DE70171594, DE73784927, DE73784925, DE73784924, DE73784923, DE73784922, DE73784856, DE73784926, DE31718527, DE31718491, DE31718489, DE31723270, DE31723263, DE31723264, DE31723266, DE31723271, DE31723272, DE31723273, DE31723279, DE31723277, DE31723278, DE31723280, DE31723274, DE31723319, DE31723329, DE31723328, DE31723323, DE31723320, DE31723322, DE31723338, DE31723340, DE31723312, DE31723325, DE31723327, DE31723342, DE31723294, DE31723315, DE31723316, DE31723341, DE31723331, DE31723332, DE31723330, DE31723334, DE31723318, DE31723317, DE31723313, DE31723295, DE31723293, DE31723292, DE31723291, DE31723290, DE31723289, DE31723288, DE31723287, DE31723286, DE31723379, DE31723333, DE31723337, DE31723376, DE31723374, DE31723336, DE31723373, DE31723371, DE31723358, DE31723335, DE57031579, DE57031597, DE57031563, DE57031569, DE57031570, DE57031568, DE60842375, DE60842339, DE60842338, DE60842382, DE61950174, DE61950202, DE61950193, DE61950179, DE61950201, DE61950173, DE76998546, DE76998543, DE70177947, DE70177945, DE70177948, DE70177949, DE70177944, DE70177952, DE70177953, DE70177954, DE70177955, DE70177956, DE70177950, DE70177942, DE70177940, DE70177941, DE70177873, DE70177877, DE70177897, DE70177908, DE70177910, DE70177937, DE70177938, DE70177939, DE31719236, DE31719271, DE31719230, DE31719221, DE31721452, DE31721416, DE31725699, DE31725705, DE57032534, DE61953982, DE61953986, DE73780012, DE73780082, DE73780081, DE73780077, DE73780071, DE73780018, DE73780011, DE73780009, DE76997660, DE76997659, DE76997655, DE76997661, DE76997654, DE76997653, DE76997652, DE76997650, DE76997649, DE76997648, DE76997647, DE76997657, DE76997662, DE76997670, DE76997667, DE76997668, DE76997669, DE76997671, DE76997672, DE76997680, DE76997678, DE76997677, DE76997676, DE76997675, DE76997674, DE76997673, DE76997663, DE76997600, DE76997599, DE76997617, DE76997616, DE76997615, DE76997614, DE76997613, DE76997611, DE76997610, DE76997609, DE76997608, DE76997607, DE76997606, DE76997618, DE76997605, DE76997603, DE76997602, DE76997601, DE76997587, DE76997581, DE76997582, DE76997583, DE76997591, DE76997592, DE76997593, DE76997595, DE76997596, DE76997597, DE76997604, DE76997619, DE76997620, DE76997641, DE76997646, DE76997644, DE76997643, DE76997642, DE76997645, DE61948585, DE61948582, DE61948577, DE61948571, DE61948526, DE61948505, DE61948501, DE61948511, DE61948506, DE61948378, DE61948486, DE61948527, DE61948519, DE61948509, DE61948507, DE61948461, DE61948498, DE61948499, DE61948500, DE61948502, DE61948503, DE61948504, DE61948512, DE61948513, DE61948540, DE61948542, DE61948547, DE61948548, DE61948508, DE61948610, DE61948598, DE61948599, DE61948601, DE61948603, DE61948604, DE61948605, DE61948606, DE61948609, DE61948619, DE61948620, DE61948624, DE61948629, DE61948617, DE61948632, DE61948637, DE61955049, DE61955050, DE61955051, DE61955057, DE61955058, DE61955075, DE61955076, DE61955078, DE61958335, DE61958336, DE61959165, DE61959271, DE61959262, DE61959912, DE61959909, DE61959890, DE61959882, DE61959864, DE70171041, DE70171037, DE70171035, DE76994467, DE76994470, DE76994473, DE76994478, DE76994479, DE76994483, DE76994497, DE76994498, DE76994499, DE76994534, DE73783648, DE73783627, DE73783654, DE73783656, DE73783655, DE73783653, DE73783652, DE73783651, DE73783650, DE73783647, DE73783649, DE73783635, DE73783634, DE73783633, DE73783632, DE73783631, DE73783630, DE73783629, DE73783646, DE73783628, DE73791259, DE73791249, DE73791248, DE73791247, DE73791246, DE73791245, DE73791241, DE73791240, DE73791239, DE73791262, DE73791242, DE73791335, DE73791243, DE73791349, DE31717108, DE31717107, DE31717092, DE31717096, DE31717097, DE31717080, DE31717082, DE31717093, DE31717095, DE31717094, DE57028896, DE60843656, DE60843658, DE60843719, DE60843720, DE61950677, DE61950679, DE61950634, DE61950640, DE61950681, DE61950683, DE60844976, DE61950140, DE61950141, DE61950142, DE61950143, DE61950144, DE61950145, DE61950146, DE61950147, DE61950148, DE61950149, DE61950150, DE61950151, DE61950152, DE61950139, DE61950138, DE61950137, DE61950136, DE61949999, DE61950026, DE61950027, DE61950028, DE61950030, DE61950054, DE61950055, DE61950057, DE61950058, DE61950059, DE61950060, DE61950061, DE61950062, DE61950133, DE61950134, DE61950135, DE61950056, DE61951364, DE61951363, DE61951377, DE61951378, DE61951375, DE61951351, DE61951357, DE61951358, DE61951376, DE61951359, DE61951347, DE61951346, DE61951345, DE61951342, DE61951341, DE61951344, DE61951366, DE61951374, DE61951373, DE61951372, DE61951371, DE61951365, DE61951370, DE61951348, DE61951362, DE61951361, DE61951368, DE61951367, DE61951369, DE70173819, DE70173817, DE70173815, DE70173814, DE70173812, DE70173810, DE70173809, DE70173808, DE70173806, DE70173805, DE70173798, DE70173822, DE73787227, DE73787226, DE73787218, DE73787216, DE73787213, DE73787212, DE73787204, DE73787193, DE73787177, DE73787174, DE73787152, DE73787148, DE73787145, DE73787139, DE73787141, DE73787182, DE73787183, DE73787185, DE73787186, DE73787191, DE73787199, DE73787201, DE31713144, DE31715414, DE57034553, DE57034561, DE57034560, DE57034554, DE57034552, DE57034562, DE57034563, DE57034573, DE57034565, DE57034540, DE57034578, DE57034577, DE57034576, DE57034575, DE57034564, DE57034547, DE57034548, DE57034569, DE57034568, DE57034567, DE57034566, DE57034542, DE57034533, DE57034538, DE57034539, DE57034546, DE57034543, DE57034544, DE57034555, DE57034556, DE57034557, DE57034582, DE57034618, DE57034619, DE57034626, DE57034629, DE57034630, DE57034631, DE57034633, DE57034635, DE57034637, DE57034638, DE57034642, DE57034643, DE57034644, DE57034572, DE57034571, DE57034617, DE57034581, DE57034615, DE57034613, DE57034583, DE57034584, DE57034585, DE57034586, DE57034590, DE57034591, DE57034592, DE57034593, DE57034595, DE57034596, DE57034597, DE57034599, DE57034600, DE57034601, DE57034602, DE57034604, DE57034607, DE57034608, DE57034614, DE57034588, DE57034594, DE769A4011, DE769A4007, DE31715354, DE31715367, DE31715353, DE31715357, DE31715489, DE31715494, DE31715987, DE31715991, DE31719748, DE31719818, DE31719781, DE57029771, DE57033770, DE57033777, DE57035610, DE57035611, DE60838770, DE60838953, DE60838955, DE60838964, DE60839432, DE60839429, DE60841819, DE60845842, DE60845841, DE60845839, DE60845843, DE61946427, DE61946428, DE61946431, DE61946420, DE61946435, DE61946445, DE61946449, DE61946450, DE61946421, DE61946426, DE61946434, DE61946811, DE61946857, DE61946858, DE61946864, DE61946848, DE61946814, DE61946865, DE61946867, DE61946810, DE61948993, DE61953120, DE61953118, DE61953116, DE61953114, DE61953113, DE61953109, DE61953106, DE61953105, DE61953103, DE61953073, DE61959102, DE61959103, DE61959111, DE70163656, DE70163666, DE70163668, DE70163669, DE70163729, DE70163719, DE70163727, DE70163731, DE70163732, DE70163730, DE70167358, DE70167413, DE70167389, DE70167399, DE70169874, DE70169894, DE70170772, DE70173932, DE70173905, DE70174944, DE70174908, DE70174903, DE70174941, DE70174942, DE70174902, DE70174940, DE70174946, DE70174947, DE70174939, DE70174951, DE70174933, DE70174978, DE70174952, DE70177289, DE70177221, DE70177291, DE70177306, DE70177308, DE70177377, DE70177376, DE70177375, DE70177374, DE70177373, DE70177621, DE70177618, DE73782822, DE73782828, DE73782824, DE73782817, DE73784271, DE73784272, DE73784273, DE73784274, DE73784275, DE73784276, DE73784256, DE73784277, DE73784279, DE73784182, DE73784184, DE73784185, DE73784189, DE73784219, DE73784278, DE73784255, DE73784254, DE73784253, DE73783754, DE73784097, DE73786785, DE73786784, DE73786802, DE73786801, DE73786800, DE73786789, DE73786788, DE73786787, DE73787564, DE73787566, DE73787567, DE73787568, DE73789046, DE73789045, DE73789044, DE73789107, DE73789104, DE73789030, DE73789050, DE73789031, DE73789052, DE73789058, DE73789054, DE73789053, DE73789051, DE73789059, DE73789049, DE73791923, DE73791928, DE73791941, DE73792131, DE73792132, DE73792226, DE73792129, DE73792130, DE73793961, DE73793967, DE76994340, DE76994341, DE76994338, DE76994352, DE76994392, DE76994339, DE76994382, DE76994377, DE76994376, DE76994375, DE76994372, DE76994351, DE76994383, DE76994391, DE76994504, DE76994538, DE76995434, DE76995435, DE76996460, DE76996456, DE76996459, DE76996463, DE76996458, DE76996465, DE76996468, DE76996471, DE76996464, DE76998667, DE76998685, DE76998682, DE76998681, DE76998678, DE76998677, DE76998671, DE76998670, DE76998669, DE76998679, DE76998668, DE769A1310, DE769A1315, DE769A1309, DE769A3479, DE769A3471, DE769A7369, DE31722080, DE31722093, DE31722087, DE31722094, DE31722084, DE31722095, DE31722097, DE31722098, DE31722083, DE31722089, DE31722294, DE31722299, DE31722307, DE31722247, DE31722295, DE31722869, DE31722870, DE31722877, DE31722878, DE31722879, DE73792201, DE73792163, DE73792157, DE73792162, DE73792156, DE73792152, DE769A0105, DE769A0110, DE769A0117, DE769A0115, DE769A0114, DE769A0101, DE31717014, DE61961517, DE61961520, DE61961515, DE61961509, DE61961526, DE61961518, DE70167570, DE70167628, DE70167608, DE70167609, DE70167619, DE70167620, DE70167629, DE73788676, DE73788681, DE73788682, DE73788683, DE73788684, DE73788692, DE73788680, DE769A6301, DE769A6383, DE769A6388, DE769A6294, DE769A6305, DE61962262, DE70165201, DE70165200, DE70165196, DE70165193, DE70165190, DE70165188, DE70165191, DE70167516, DE70167514, DE70167308, DE73788223, DE73788222, DE73788217, DE73788224, DE73788225, DE73788234, DE73788227, DE73788235, DE73788226, DE73787941, DE73788231, DE73788216, DE73788232, DE73788230, DE73788219, DE76998399, DE76998405, DE31726581, DE31726579, DE31726578, DE31726574, DE57026604, DE57026603, DE57026598, DE57026589, DE70165435, DE70165400, DE70165414, DE70165425, DE70165436, DE70165437, DE70165439, DE31720458, DE31720451, DE31720484, DE31720447, DE31720479, DE31720475, DE31720473, DE31720465, DE31720472, DE31720469, DE31720450, DE31720452, DE31720449, DE31720454, DE31720466, DE31720478, DE31720463, DE31720461, DE31720460, DE31720459, DE31720457, DE31720467, DE31720456, DE31720470, DE70166311, DE70166245, DE70166315, DE70166244, DE70166314, DE70166312, DE70166308, DE70166307, DE70166299, DE70166298, DE70166240, DE70166297, DE70166226, DE70166227, DE70166230, DE70166295, DE60839691, DE60839690, DE60839689, DE60839686, DE60839696, DE73792179, DE73792194, DE73792180, DE73792191, DE76999488, DE76999489, DE76999493, DE769A0043, DE769A0045, DE769A0098, DE769A0096, DE769A0095, DE769A0080, DE769A0053, DE769A0054, DE769A0059, DE769A0081, DE769A0061, DE769A0063, DE769A0064, DE769A0065, DE769A0066, DE769A0067, DE769A0075, DE769A0060, DE769A5683, DE769A5681, DE769A5670, DE769A5675, DE31724536, DE31714245, DE57029321, DE57030505, DE57031408, DE57032365, DE70177798, DE70177796, DE70177799, DE31721208, DE61961186, DE61961187, DE61961140, DE61961139, DE61961137, DE61961153, DE61961181, DE61961180, DE61961179, DE61961178, DE61961177, DE61961176, DE61961154, DE61961185, DE61961183, DE61961146, DE61961182, DE61961144, DE61961142, DE61961141, DE61961174, DE61961143, DE61961191, DE61961175, DE61961150, DE61961163, DE61961148, DE61961162, DE61961161, DE61961160, DE61961149, DE61961159, DE61961158, DE61961157, DE61961156, DE61961151, DE61961152, DE61961155, DE61961196, DE61961193, DE61961194, DE61961171, DE61961126, DE61961125, DE61961122, DE61961120, DE61961164, DE61961166, DE61961049, DE61961167, DE61961170, DE61961168, DE61961169, DE61961889, DE61961893, DE61961894, DE61961880, DE61961895, DE61961882, DE61961883, DE61961884, DE61961885, DE61961886, DE61961892, DE61961891, DE61961890, DE61961887, DE61961888, DE61961881, DE61961896, DE61961929, DE61961898, DE61961897, DE61961944, DE61961900, DE61961902, DE61961903, DE61961906, DE61961912, DE61961916, DE61961917, DE61961920, DE61961921, DE61961922, DE61961923, DE61961924, DE61961925, DE61961926, DE61961899, DE61961928, DE61961927, DE61961940, DE61961939, DE61961938, DE61961937, DE61961943, DE61961934, DE61961933, DE61961932, DE61961931, DE61961930, DE70166423, DE70166542, DE70166541, DE70166539, DE70166538, DE70166537, DE70166535, DE70166518, DE70166536, DE70166489, DE70166490, DE70166491, DE70166534, DE70166533, DE70166493, DE70166424, DE70166441, DE70166637, DE70166638, DE70166419, DE70166636, DE70166443, DE70166442, DE70166440, DE70166439, DE70166435, DE70166457, DE70166543, DE70166467, DE70166466, DE70166465, DE70166464, DE70166463, DE70166462, DE70166461, DE70166460, DE70166459, DE70166436, DE70166434, DE70166430, DE70166421, DE70166420, DE70166416, DE70166415, DE70166414, DE70166412, DE70166411, DE70166468, DE70166469, DE70166470, DE70166471, DE70166487, DE70166483, DE70166481, DE70166361, DE70166359, DE70166540, DE70166409, DE70166486, DE70166484, DE70166480, DE70166479, DE70166478, DE70166477, DE70166476, DE70166475, DE70166474, DE70166472, DE70166485, DE70166408, DE70166407, DE70166406, DE70166512, DE70166513, DE70166514, DE70166515, DE70166516, DE70166517, DE70166405, DE70166404, DE70166403, DE70166511, DE70166402, DE70166400, DE70166399, DE70166364, DE70166495, DE70166358, DE70166356, DE70166343, DE70166545, DE70166544, DE70166401, DE70166456, DE70166510, DE70166508, DE70166410, DE70166422, DE70166426, DE70166427, DE70166428, DE70166429, DE70166431, DE70166432, DE70166433, DE70166509, DE70166437, DE70166492, DE70166499, DE70166501, DE70166502, DE70166503, DE70166505, DE70166506, DE70166507, DE70166482, DE70166496, DE70166634, DE70166635, DE70166498, DE70166528, DE70166527, DE70166526, DE70166525, DE70166524, DE70166523, DE70166529, DE70166453, DE70166455, DE70166522, DE70166521, DE70166520, DE70166519, DE70166500, DE70166458, DE70166454, DE70166451, DE70166449, DE70166532, DE70166531, DE70166546, DE70166547, DE70166548, DE70166554, DE70166558, DE70166450, DE70166560, DE70166564, DE70166444, DE70166488, DE70166445, DE70166446, DE70166447, DE70166448, DE70166530, DE70166580, DE70166627, DE70166629, DE70166630, DE70166497, DE70166631, DE70166633, DE70167566, DE70167604, DE31713342, DE70163610, DE70163686, DE70169932, DE61946073, DE61953924, DE61953928, DE31717780, DE70167086, DE70167101, DE70167106, DE70167111, DE70167112, DE70167113, DE70167078, DE70167077, DE70167076, DE70167075, DE70167060, DE70167061, DE70167063, DE70167064, DE70167065, DE70167066, DE70167067, DE70167068, DE70167071, DE70167119, DE70167072, DE57033988, DE57034598, DE57034603, DE60845022, DE61946632, DE61946630, DE61957457, DE61957455, DE61957452, DE76997358, DE76997357, DE76997354, DE76997346, DE76997359, DE76997360, DE76997361, DE76997366, DE76997367, DE76997368, DE76997378, DE76997386, DE60845048, DE60844607, DE61958357, DE61961412, DE61961413, DE61961432, DE61961433, DE61961435, DE61961439, DE61961442, DE70170702, DE70170699, DE70176775, DE70176774, DE70176773, DE70176758, DE70176776, DE70176777, DE70176779, DE70176784, DE70176783, DE70176781, DE70176780, DE70176778, DE73780769, DE73780772, DE73780773, DE73780778, DE73780775, DE73780776, DE73780780, DE73780782, DE73780774, DE73780715, DE73780770, DE73780570, DE769A5888, DE70168404, DE60836117, DE60836118, DE60836123, DE60836122, DE60836116, DE60836113, DE60836112, DE60836108, DE60836107, DE60836097, DE60836101, DE60836102, DE60836114, DE60836103, DE60836106, DE60836105, DE31723175, DE31724586, DE31724564, DE31724562, DE31724561, DE57029055, DE57029054, DE57029047, DE57029046, DE57029045, DE57029042, DE57029037, DE76995182, DE76997128, DE76997112, DE76997083, DE76997133, DE76997113, DE76997114, DE76997115, DE76997116, DE76997130, DE76997127, DE76999909, DE76999911, DE76999912, DE76999913, DE76999914, DE76999918, DE76999916, DE61948010, DE31715544, DE31715538, DE76996552, DE76996557, DE76996614, DE76996566, DE76996605, DE76996609, DE76996555, DE76996548, DE57032099, DE57032101, DE57032110, DE57032103, DE57032107, DE57032108, DE57032111, DE57032102, DE57032091, DE57034174, DE57034228, DE70164522, DE70168712, DE70169157, DE70169714, DE73791057, DE73791053, DE73791054, DE73791058, DE73791055, DE73791066, DE73791065, DE73791063, DE73791059, DE73779930, DE73779995, DE57027122, DE57027135, DE57027136, DE57027117, DE57027119, DE57027134, DE57027133, DE57027128, DE57027125, DE57027123, DE57027118, DE60844339, DE60844355, DE61946979, DE61947005, DE61946997, DE61946996, DE61946995, DE61946992, DE61946920, DE61946929, DE61946930, DE61946931, DE61946975, DE61946976, DE61946977, DE61946991, DE61946980, DE61946984, DE73780179, DE73780189, DE73780191, DE73786537, DE73786533, DE73786532, DE73788239, DE73788294, DE73788306, DE73788252, DE73788248, DE73788241, DE73788303, DE73788236, DE73788250, DE73788249, DE73788246, DE73788242, DE73788210, DE73788329, DE73788311, DE73788245, DE60843118, DE60844185, DE60841044, DE60841106, DE60841060, DE60841052, DE60841102, DE61956197, DE61956205, DE73780206, DE73780216, DE73791142, DE73791143, DE76998903, DE76998902, DE76998900, DE76998909, DE76998896, DE31713520, DE31716438, DE31714198, DE31714189, DE31719487, DE31719479, DE31719414, DE31719471, DE31719481, DE31719484, DE31719485, DE31719486, DE61946060, DE61946059, DE61946068, DE61946067, DE61946063, DE61946058, DE61946052, DE61946056, DE61946057, DE61946053, DE61946055, DE61946054, DE61957928, DE61957932, DE61962216, DE61962215, DE70163810, DE61949292, DE61949300, DE61949301, DE61949294, DE70164652, DE70164649, DE70164647, DE70164646, DE70164645, DE70164644, DE70164694, DE70164693, DE70164690, DE70164682, DE70164680, DE70164677, DE70164675, DE70164673, DE70164670, DE70164669, DE70164667, DE70164666, DE70164664, DE70164654, DE70164656, DE70164663, DE70164662, DE70164658, DE70164657, DE70164655, DE73789016, DE73789024, DE73789009, DE73789010, DE73789025, DE73789006, DE73789023, DE73792374, DE73792376, DE73792381, DE73792379, DE73792377, DE73792375, DE76998202, DE76998117, DE76998115, DE76998110, DE76998109, DE76998207, DE76998203, DE76998189, DE76998188, DE76998108, DE60842193, DE60842210, DE60842211, DE60842212, DE60842213, DE60842214, DE60842215, DE60842216, DE60842223, DE60842224, DE61960702, DE61960711, DE70165402, DE70165408, DE70165403, DE70165409, DE70165407, DE70165424, DE70165423, DE70165421, DE70165420, DE70165411, DE70165410, DE70165418, DE70171709, DE70171708, DE70171704, DE70171710, DE70171703, DE70171701, DE769A3228, DE769A3200, DE769A3229, DE769A3230, DE769A3233, DE769A3234, DE769A3231, DE769A3232, DE61954763, DE61954767, DE61954775, DE61954770, DE61954768, DE61954766, DE61959895, DE61959893, DE61959900, DE61959892, DE61959886, DE61959883, DE61959816, DE61959800, DE61959889, DE61959813, DE61959798, DE61959814, DE73785475, DE73785460, DE73785191, DE70176322, DE70176319, DE70176321, DE70176318, DE70176309, DE70177709, DE70177698, DE70177697, DE70177694, DE60844717, DE60844691, DE60844699, DE60844737, DE60844729, DE60844728, DE60844727, DE60844726, DE60844725, DE60844723, DE60844692, DE60844722, DE60844721, DE60844720, DE60844719, DE60844718, DE60844716, DE60844715, DE60844714, DE60844713, DE60844724, DE60844712, DE61946767, DE61946768, DE61946769, DE61946770, DE61946771, DE61946772, DE61946774, DE61946775, DE61946782, DE61946783, DE61946792, DE61946773, DE61960211, DE61960224, DE61960225, DE61960212, DE61960202, DE61960201, DE61960275, DE70173231, DE70173232, DE70173061, DE70173060, DE70173059, DE70173057, DE70173054, DE70173051, DE70173046, DE70173044, DE769A3338, DE769A3334, DE769A3332, DE769A3329, DE769A3328, DE769A3327, DE769A3326, DE769A3324, DE769A3320, DE769A3331, DE70168189, DE70168194, DE70168595, DE70168414, DE70168411, DE70168600, DE70168601, DE70168602, DE70168603, DE70168605, DE70168610, DE70168597, DE70168405, DE70168122, DE70168386, DE70168095, DE70168097, DE70168100, DE70168101, DE70168102, DE70168103, DE70168105, DE70168107, DE70168108, DE70168117, DE70168120, DE70168121, DE70168612, DE70168124, DE70168217, DE70168613, DE70168412, DE70168614, DE70175916, DE70175873, DE76995172, DE76995173, DE76995155, DE76995171, DE76997216, DE76997209, DE769A3001, DE769A3002, DE769A3006, DE769A3010, DE769A3012, DE769A3013, DE769A3016, DE769A3017, DE769A3015, DE769A3019, DE769A3018, DE769A3052, DE769A3054, DE769A3059, DE769A3043, DE769A3044, DE769A3046, DE769A3057, DE769A3058, DE769A3060, DE31716793, DE61948376, DE61948375, DE61948371, DE61948367, DE61948366, DE61949403, DE61949424, DE61949423, DE61949428, DE61949427, DE61949410, DE61949422, DE61949425, DE61949421, DE61949392, DE61949393, DE61949401, DE61949402, DE61949426, DE61959072, DE61959074, DE61959061, DE70169341, DE70169048, DE70169205, DE70169216, DE70169215, DE70169213, DE70169092, DE70169220, DE70169221, DE70169223, DE70169309, DE70169315, DE70169212, DE70169211, DE70169210, DE70169209, DE70169208, DE70169207, DE70169206, DE70169219, DE70170949, DE70170947, DE70170924, DE70170925, DE70170940, DE70170946, DE70170944, DE70175911, DE70175912, DE70175910, DE70175913, DE70175918, DE70175914, DE70175908, DE70175915, DE70177933, DE70177932, DE70177923, DE70177919, DE70177929, DE73780271, DE73780270, DE73780269, DE73780273, DE73780268, DE73780272, DE73780267, DE73780275, DE73780276, DE73780277, DE73780278, DE73780279, DE73780280, DE73780281, DE73780282, DE73780274, DE73780266, DE73780320, DE73780264, DE73780325, DE73780324, DE73780323, DE73780322, DE73780321, DE73780318, DE73780317, DE73780316, DE73780315, DE73780314, DE73780326, DE73780313, DE73780311, DE73780310, DE73780309, DE73780308, DE73780307, DE73780306, DE73780305, DE73780304, DE73780303, DE73780312, DE73780327, DE73780319, DE73780329, DE73780263, DE73780006, DE73780005, DE73780342, DE73780341, DE73780328, DE73780337, DE73780336, DE73780335, DE73780339, DE73780330, DE73780331, DE73780332, DE73780333, DE73780265, DE73783489, DE73783476, DE73784139, DE73784122, DE73791149, DE73791137, DE73792412, DE73792415, DE73792411, DE73792286, DE73792288, DE73792326, DE73792400, DE73792401, DE73792405, DE73792406, DE73792268, DE73792407, DE73792408, DE73792409, DE73792597, DE73792539, DE73792451, DE73792449, DE73792450, DE73792538, DE76996413, DE76996412, DE76997248, DE76997231, DE76997236, DE76997241, DE76997245, DE76997246, DE76997249, DE76997251, DE76997257, DE76997258, DE76999889, DE76999890, DE31714405, DE31714392, DE31714420, DE31714398, DE31714543, DE31714581, DE31714576, DE31714545, DE31714547, DE31714549, DE31714550, DE31714552, DE31714554, DE31714557, DE31714560, DE31714561, DE31714539, DE31714537, DE31714535, DE31714533, DE31714563, DE31714562, DE31714556, DE31714553, DE31714546, DE31714544, DE31714542, DE31714534, DE31714532, DE31714589, DE31714583, DE31714582, DE31714540, DE31714580, DE31714579, DE31714575, DE31714548, DE31719977, DE31719969, DE31719974, DE31719965, DE31719957, DE31719995, DE31719994, DE31719986, DE31719983, DE31719979, DE31719981, DE31719980, DE31721920, DE31721945, DE31721929, DE31721934, DE31725242, DE31725233, DE31725235, DE31725244, DE31725234, DE57029531, DE57029546, DE57029530, DE57029527, DE57029488, DE57029543, DE57029544, DE57029547, DE57029545, DE57029541, DE57029542, DE57032876, DE57032878, DE60838569, DE60838566, DE60838560, DE60838561, DE60838563, DE60838567, DE60838568, DE60838576, DE60838577, DE60838582, DE61958313, DE61958318, DE61958317, DE61958316, DE61958300, DE61958299, DE70177916, DE70177985, DE70178043, DE70178003, DE70178004, DE70178010, DE70178005, DE70178008, DE70178009, DE70178011, DE70178013, DE70178035, DE70178034, DE70178033, DE70178032, DE70178014, DE70178015, DE70178016, DE70178017, DE70178018, DE70178029, DE70178030, DE70178037, DE70178031, DE70178025, DE70178024, DE70178022, DE70178021, DE70178020, DE70178019, DE70178026, DE70178027, DE70178028, DE70178065, DE70178001, DE70177998, DE70178058, DE70177999, DE70178000, DE70178002, DE70178070, DE70178074, DE31717231, DE31717234, DE31717496, DE31718842, DE73793574, DE73793581, DE73793619, DE73793631, DE73793632, DE73793635, DE73793636, DE73793640, DE73793642, DE73793644, DE73793645, DE73793646, DE73793647, DE73793648, DE73793650, DE73793638, DE76994188, DE76994187, DE76994182, DE76994184, DE76997424, DE76997423, DE76997421, DE76997417, DE76997416, DE76997411, DE769A1373, DE769A1637, DE769A1586, DE769A2204, DE769A2211, DE769A2215, DE70162561, DE70162562, DE70162563, DE70162560, DE70162566, DE70162567, DE70162573, DE70162575, DE70162578, DE70162564, DE61959412, DE57028186, DE57028185, DE70174247, DE70174294, DE70174253, DE70174252, DE70174251, DE70174328, DE70174246, DE70174296, DE70174305, DE60837592, DE60837591, DE60837590, DE60837589, DE60837588, DE60837587, DE60837585, DE60837584, DE60837583, DE60837621, DE60837614, DE60837613, DE60837612, DE60837610, DE60837599, DE60837622, DE60837623, DE60837624, DE60837625, DE60837626, DE60837627, DE60837598, DE60837597, DE60837628, DE60837596, DE60837594, DE60837593, DE60837620, DE60837582, DE60837580, DE60837639, DE60837638, DE60837637, DE60837636, DE60837635, DE60837634, DE60837633, DE60837632, DE60837631, DE60837630, DE60837581, DE60837616, DE60837573, DE60837570, DE60837629, DE60839668, DE60839667, DE60839608, DE60839666, DE60839669, DE60839670, DE60839609, DE60839606, DE60839569, DE60839568, DE60839732, DE60839734, DE60839735, DE60839736, DE60839737, DE60839571, DE60839604, DE60839728, DE60839671, DE60839725, DE60839724, DE60839723, DE60839722, DE60839721, DE60839720, DE60839719, DE60839718, DE60839717, DE60839716, DE60839715, DE60839714, DE60839713, DE60839712, DE60839711, DE60839709, DE60839708, DE60839707, DE60839706, DE60839677, DE60839676, DE60839675, DE60839674, DE60839673, DE60839672, DE60839727, DE60839730, DE60839743, DE60839748, DE60839729, DE60843406, DE60843402, DE60843401, DE60843400, DE60843399, DE60843407, DE60843393, DE60843392, DE60843391, DE60843390, DE60843388, DE60843398, DE60843403, DE60843405, DE60843404, DE60843387, DE60843732, DE60843721, DE60843716, DE60843722, DE73784135, DE73784229, DE73784227, DE73787450, DE73787448, DE73787447, DE73787444, DE73787443, DE73787441, DE73787439, DE73787436, DE73787435, DE73787433, DE769A4849, DE769A4850, DE31725748, DE31725768, DE31725763, DE31725762, DE31725761, DE31725754, DE31725760, DE31725746, DE31725756, DE31725750, DE31725751, DE31725747, DE31725755, DE31725759, DE31725745, DE31725757, DE31720267, DE31720320, DE61950780, DE61950779, DE61950781, DE61950764, DE61950778, DE61950776, DE61950777, DE61950783.

Distribution pattern

US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

device · product 2 of 5

IntelliVue Patient Monitor MX400. Model Number: 866060

Z-1107-2025

Recall number: Z-1107-2025
Initiated: January 15, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Code information

Model Number: 866060. UDI-DI Number: (01)00884838038752(21). Serial Numbers: DE35174105, DE35174084, DE35174083, DE35174082, DE35174080, DE35107369, DE35108320, DE35160410, DE671M4116, DE7770DA9W, DE35114616, DE35114618, DE671E8921, DE671E8917, DE7580AH50, DE7580AHEH, DE35123130, DE671V9297, DE671V9296, DE671V9298, DE35160989, DE35160994, DE35160988, DE35161272, DE35161273, DE35161274, DE7580B537, DE7580B52H.

Distribution pattern

US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

device · product 3 of 5

IntelliVue Patient Monitor MX450. Model Number: 866062

Z-1108-2025

Recall number: Z-1108-2025
Initiated: January 15, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 98 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Code information

Model Number: 866062. UDI-DI: (01)00884838038769(21); Serial Numbers: DE35169761, DE671V3903, DE671V3885, DE671V7898, DE7770DC1L. UDI-DI: 884838045859; Serial Numbers: DE32303399, DE32302479, DE32302480, DE32306956, DE35131294, DE35114613, DE35114612, DE671T9641, DE7770C86L, DE7770C86K, DE7770C86J, DE7770C86H, DE7770C86G, DE35120431, DE671K3731, DE671K3729, DE671K3706, DE671K3796, DE671K3816, DE671K3737, DE671K3773, DE671L0436, DE671L0462, DE671L0406, DE671L5214, DE671L5207, DE671L5206, DE671L5181, DE671L5169, DE671M3993, DE671M4048, DE671M4036, DE671M4037, DE671M4053, DE671M7009, DE671M7012, DE671M9968, DE671M9972, DE671M9963, DE671N0009, DE671N0010, DE671N0092, DE671N0008, DE671N0001, DE671N0002, DE671M9985, DE671M9999, DE671N0000, DE671P0411, DE671P1094, DE671P2457, DE671P2537, DE32306016, DE32306017, DE32306018, DE7580B4PC, DE7580B4PB, DE7580B4PA, DE7770C6ZP, DE7770C74Y, DE7770C74Z, DE7770C750, DE7770C74W, DE7770C74V, DE7770C78E, DE7770C78D, DE7770D6LH, DE7770D6LG, DE7770D6LF, DE7770D6LE, DE35142704, DE35142703, DE35142705, DE35142702, DE35142706, DE35182894, DE32301491, DE32301476, DE32301477, DE32301478, DE32301479, DE32301480, DE32301481, DE32301482, DE32301483, DE32301484, DE32301485, DE32301486, DE32301487, DE32301488, DE32301489, DE32301490, DE32301506.

Distribution pattern

US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

device · product 4 of 5

IntelliVue Patient Monitor MX500. Model Number: 866064

Z-1109-2025

Recall number: Z-1109-2025
Initiated: January 15, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Code information

Model Number: 866064. UDI-DI: (01)00884838038776(21); Serial Numbers: DE7580A1R5, DE7580A1R4, DE7580A1R1, DE7580A1R0, DE7580A1PM, DE7580A1PL, DE7580A1PK, DE7580A1PJ, DE7580A1P5, DE351C8913, DE351C8912, DE351C8908, DE351C8911, DE351C8910, DE351C8909, DE32300881, DE32300882, DE32300883, DE32300937, DE32300936, DE32301099, DE35114607, DE35114606, DE671T0786, DE671K1669, DE671V9213, DE35133301, DE671N0625, DE671E0967, DE671E0964, DE671E0965, DE671E0968, DE671E0978, DE671E1009, DE671E1008, DE671E1007, DE671E1006, DE671E1005, DE671E1004, DE671E0977, DE671E1003, DE671E0979, DE671E1015, DE671E0966, DE671E1059.

Distribution pattern

US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

device · product 5 of 5

IntelliVue Patient Monitor MX550. Model Number: 866066

Z-1110-2025

Recall number: Z-1110-2025
Initiated: January 15, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 74 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

Code information

Model Number: 866066. UDI-DI: (01)00884838038783(21); Serial Numbers: DE671E3020, DE671E2989, DE671E2988, DE671E3086, DE671E3085, DE671E3084, DE671E3097, DE671E3096, DE671E3095, DE671E3094, DE671E3093, DE671E3253, DE671E3246, DE671E3245, DE671E3244, DE671E3241, DE671E3240, DE671E3234, DE671E3235, DE671E3238, DE671E3239, DE671E3021, DE671E3236, DE671E3865, DE671E3863, DE671E3862, DE671E3861, DE671E3860, DE671E3859, DE671E3858, DE671E3857, DE671E3856, DE671E3855, DE671E3853, DE671E3852, DE671E3867, DE671E3871, DE671E3730, DE671E3729, DE671E3866, DE35186967, DE35186949, DE35186948, DE35186947, DE35186944, DE35186943, DE35186942, DE35186941, DE35186940, DE35186939, DE35186938, DE35186982, DE35186945, DE35199396, DE35199398, DE35199428, DE671E2030, DE671H1334, DE32302561, DE32302562, DE32301002, DE32301003, DE32301004, DE35114609, DE35114608, DE758Y7635, DE758Y7616, DE758Y7619, DE758Y7615, DE758Y7614, DE7580AWK6, DE7580AWK7, DE7580AWKB, DE7580AWK4.

Distribution pattern

US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.