Z-2206-2025Class II
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103
Philips North America LLC / initiated 2025-06-30 / Open, Classified / root cause: design
Philips North America began a recall of Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103 on . FDA classified it as Class II and gives the reason as "The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2206-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- Reason for recall
- The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- On June 30, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users 4.1. When using any affected system identified according to the information in section 3, follow the instructions below. 4.2. Pay particular attention if a scan interruption occurs and a scan abort symbol is encountered, which may appear in the user interface (UI) with the symbols shown in Figure 4 below: Figure 4. Scan Abort Symbols 4.3. When scan aborts occur the symbol is shown and applicable messages are presented in the message box (see Figure 5 and Figure 6 examples) 4.3.1. Check the status of the error messages in the User Interface (UI) screen. Click to expand the message box in case previous messages are hidden, see orange box in Figure 5 and Figure 6 below. If possible, correct the issue that is relevant to the error shown and continue scanning, for example: RF door must be closed while performing scan. Scan aborted. Patient support is moved while scanning, scan stopped. Coil A (or B) failure, coil disconnected? . 4.3.2. If, after a scan abort, one of the following conditions occur five times in a row stop scanning immediately and contact Philips Service to describe the problem: If there is no error message in the message box If the error message meaning is not clear 4.3.3. If the error message Gradient amplifier Rack Fault is received two times in a row, or if the error message Gradient amplifier Rack Fault is preceded or followed by an aborted scan with no message, then stop scanning immediately and contact Philips Service to describe the problem. 4.3.4. If you encounter any of these conditions described in 4.3.2 or 4.3.3 do not attempt any additional/further scans, including without limitation do not attempt any phantom scanning until your system has been checked and released by a Philips Service representative. 4.4. If smoke and/or fire is detected
- Quantity in commerce
- 1,467 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.
- Product codes and lots
- Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103; UDI-DI: (1) 00884838055339, (2) 00884838009813, (3) 00884838098299; Serial Numbers: (1) 71001, 71002, 71003, 71004, 71006, 71007, 71008, 71010, 71011, 71012, 71013, 71014, 71016, 71018, 71020, 71022, 71023, 71026, 71027, 71029, 71031, 71035, 71037, 71038, 71039, 71040, 71045, 71047, 71051, 71055, 71056, 71058, 71060, 71061, 71062, 71064, 71065, 71068, 71070, 71071, 71072, 71073, 71074, 71077, 71078, 71081, 71084, 71086, 71087, 71088, 71089, 71093, 71095, 71097, 71101, 71106, 71107, 71150, 71152, 71153, 71154, 71155, 71156, 71157, 71159, 71162, 71163, 71164, 71165, 71166, 71168, 71170, 71172, 71173, 71174, 71175, 71176, 71177, 71179, 71181, 71183, 71184, 71185, 71187, 71188, 71189, 71190, 71192, 71193, 71194, 71195, 71197, 71198, 71200, 71203, 71204, 71208, 71210, 71211, 71213, 71214, 71215, 71216, 71220, 71224, 71225, 71227, 71228, 71231, 71252, 71260, 71262, 71263, 71266, 71267, 71268, 71269, 71270, 71271, 71272, 71275, 71276, 71277, 71279, 71280, 71282, 71283, 71285, 71286, 71287, 71288, 71290, 71291, 71296, 71297, 71298, 71299, 71300, 71301, 71302, 71303, 71304, 71305, 71307, 71308, 71309, 71311, 71312, 71313, 71314, 71315, 71317, 71318, 71319, 71320, 71321, 71322, 71323, 71324, 71326, 71327, 71328, 71329, 71331, 71332, 71333, 71334, 71335, 71336, 71337, 71338, 71339, 71340, 71341, 71342, 71343, 71344, 71345, 71346, 71347, 71349, 71350, 71351, 71352, 71353, 71354, 71355, 71356, 71357, 71358, 71359, 71360, 71361, 71362, 71363, 71364, 71365, 71367, 71368, 71369, 71370, 71371, 71372, 71373, 71374, 71375, 71376, 71377, 71378, 71379, 71380, 71381, 71382, 71384, 71385, 71386, 71387, 71388, 71389, 71390, 71392, 71393, 71394, 71395, 71396, 71397, 71398, 71399, 71400, 71401, 71402, 71403, 71405, 71406, 71407, 71408, 71409, 71410, 71411, 71412, 71413, 71414, 71415, 71416, 71418, 71419, 71420, 71422, 71423, 71424, 71425, 71426, 71427, 71428, 71429, 71433, 71434, 71436, 71437, 71438, 71440, 71441, 71442, 71443, 71444, 71445, 71446, 71448, 71449, 71450, 71451, 71452, 71453, 71456, 71457, 71459, 71460, 71461, 71462, 71463, 71464, 71465, 71467, 71468, 71470, 71471, 71472, 71473, 71474, 71475, 71476, 71477, 71478, 71479, 71480, 71481, 71482, 71483, 71484, 71485, 71486, 71487, 71489, 71490, 71491, 71492, 71493, 71495, 71496, 71497, 71498, 71499, 71501, 71505, 71506, 71509, 71510, 71511, 71512, 71513, 71514, 71516, 71517, 71518, 71519, 71520, 71521, 71522, 71524, 71526, 71527, 71529, 71532, 71534, 71541, 71544, 71545, 71548, 71550, 71551, 71553, 71554, 71555, 71556, 71557, 71558, 71559, 71560, 71562, 71563, 71564, 71565, 71566, 71567, 71569, 71570, 71571, 71574, 71575, 71576, 71577, 71580, 71581, 71582, 71583, 71584, 71587, 71588, 71589, 71590, 71592, 71594, 71596, 71597, 71599, 71600, 71601, 71602, 71603, 71604, 71605, 71607, 71608, 71609, 71610, 71614, 71615, 71616, 71618, 71619, 71620, 71621, 71622, 71623, 71624, 71625, 71626, 71628, 71629, 71630, 71631, 71633, 71634, 71635, 71637, 71639, 71640, 71641, 71642, 71643, 71644, 71645, 71646, 71647, 71648, 71649, 71650, 71651, 71652, 71653, 71654, 71655, 71656, 71658, 71659, 71660, 71662, 71665, 71667, 71668, 71669, 71670, 71671, 71673, 71674, 71675, 71676, 71677, 71678, 71679, 71680, 71681, 71682, 71683, 71684, 71685, 71686, 71687, 71688, 71689, 71690, 71691, 71692, 71693, 71694, 71695, 71697, 71698, 71699, 71700, 71702, 71703, 71704, 71706, 71707, 71708, 71709, 71710, 71711, 71713, 71714, 71715, 71716, 71717, 71721, 71722, 71723, 71725, 71726, 71729, 71730, 71732, 71733, 71734, 71735, 71737, 71738, 71739, 71740, 71742, 71743, 71744, 71745, 71746, 71748, 71749, 71750, 71751, 71752, 71754, 71755, 71756, 71757, 71758, 71759, 71760, 71762, 71763, 71764, 71765, 71766, 71767, 71771, 71772, 71773, 71775, 71778, 71779, 71780, 71781, 71782, 71783, 71784, 71785, 71786, 71788, 71789, 71790, 71791, 71796, 71800, 71801, 71802, 71804, 71805, 71806, 71807, 71808, 71810, 71812, 71813, 71814, 71816, 71817, 71818, 71819, 71820, 71821, 71822, 71823, 71825, 71826, 71827, 71828, 71829, 71831, 71833, 71834, 71838, 71839, 71840, 71841, 71842, 71844, 71848, 71849, 71850, 71851, 71852, 71853, 71854, 71856, 71858, 71859, 71860, 71861, 71862, 71863, 71864, 71867, 71868, 71869, 71871, 71872, 71874, 71875, 71876, 71877, 71878, 71879, 71880, 71881, 71882, 71884, 71885, 71887, 71889, 71891, 71892, 71893, 71894, 71895, 71896, 71897, 71898, 71899, 71900, 71908, 71909, 71910, 71911, 71913, 71914, 71916, 71917, 71918, 71919, 71920, 71921, 71922, 71923, 71924, 71925, 71926, 71928, 71930, 71931, 71935, 71936, 71944, 71945, 71946, 71948, 71949, 71951, 71952, 71953, 71954, 71956, 71957, 71958, 71959, 71960, 71962, 71963, 71964, 71966, 71967, 71972, 71973, 71976, 71977, 71979, 71982, 71983, 71984, 71986, 71987, 71988, 71991, 71992, 71993, 71994, 71996, 71997, 71998, 71999, 85000, 85002, 85003, 85004, 85005, 85006, 85009, 85010, 85011, 85012, 85015, 85016, 85018, 85019, 85020, 85021, 85022, 85023, 85024, 85025, 85026, 85028, 85031, 85032, 85034, 85036, 85037, 85038, 85042, 85044, 85045, 85046, 85047, 85048, 85049, 85050, 85054, 85056, 85057, 85059, 85061, 85063, 85064, 85065, 85066, 85067, 85068, 85069, 85070, 85073, 85074, 85075, 85076, 85078, 85079, 85080, 85081, 85082, 85083, 85085, 85087, 85089, 85091, 85092, 85094, 85095, 85096, 85097, 85098, 85099, 85101, 85102, 85105, 85106, 85109, 85111, 85112, 85114, 85121, 85122, 85123, 85124, 85125, 85126, 85127, 85132, 85136, 85140, 85141, 85142, 85143, 85145, 85147, 85148, 85149, 85150, 85151, 85152, 85153, 85154, 85155, 85157, 85160, 85161, 85162, 85166, 85168, 85169, 85170, 85171, 85172, 85174, 85177, 85178, 85180, 85181, 85183, 85184, 85185, 85186, 85187, 85188, 85189, 85190, 85191, 85192, 85193, 85195, 85197, 85198, 85199, 85200, 85201, 85202, 85203, 85204, 85205, 85206, 85208, 85209, 85210, 85213, 85215, 85216, 85217, 85218, 85219, 85220, 85221, 85222, 85223, 85224, 85226, 85230, 85231, 85232, 85233, 85234, 85236, 85237, 85238, 85241, 85242, 85243, 85245, 85246, 85247, 85249, 85250, 85251, 85253, 85258, 85259, 85260, 85263, 85265, 85268, 85269, 85270, 85272, 85275, 85276, 85277, 85278, 85279, 85280, 85282, 85283, 85284, 85285, 85286, 85288, 85290, 85291, 85294, 85295, 85300, 85301, 85302, 85303, 85304, 85305, 85306, 85309, 85310, 85311, 85312, 85313, 85314, 85316, 85317, 85318, 85319, 85321, 85322, 85323, 85325, 85329, 85330, 85332, 85333, 85334, 85335, 85336, 85339, 85340, 85341, 85342, 85344, 85345, 85346, 85347, 85348, 85349, 85350, 85351, 85353, 85354, 85355, 85356, 85357, 85358, 85359, 85360, 85361, 85362, 85364, 85365, 85366, 85367, 85368, 85369, 85370, 85371, 85372, 85373, 85374, 85375, 85376, 85377, 85378, 85380, 85381, 85382, 85383, 85384, 85385, 85386, 85387, 85388, 85389, 85390, 85391, 85392, 85393, 85396, 85397, 85398, 85399, 85400, 85401, 85402, 85403, 85406, 85407, 85408, 85412, 85413, 85414, 85415, 85416, 85417, 85418, 85419, 85420, 85421, 85422, 85425, 85426, 85427, 85428, 85429, 85430, 85431, 85432, 85433, 85434, 85436, 85439, 85440, 85442, 85447, 85448, 85449, 85450, 85453, 85454, 85455, 85456, 85457, 85458, 85459, 85460, 85461, 85462, 85463, 85466, 85467, 85468, 85469, 85470, 85471, 85476, 85478, 85479, 85480, 85481, 85483, 85484, 85485, 85487, 85488, 85490, 85491, 85494, 85496, 85497, 85498, 85499, 85501, 85504, 85506, 85507, 85509, 85510, 85515, 85517, 85518, 85519, 85522, 85524, 85525, 85526, 85527, 85528, 85531, 85532, 85533, 85535, (2) 36, 38016, 42001, 42002, 42004, 42005, 42006, 42007, 42008, 42009, 42010, 42011, 42012, 42013, 42014, 42015, 42018, 42019, 42021, 42025, 42026, 42027, 42028, 42031, 42032, 42033, 42034, 42035, 42036, 42038, 42040, 42041, 42042, 42043, 42044, 42045, 42047, 42048, 42050, 42052, 42053, 42055, 42056, 42057, 42059, 42061, 42065, 42067, 42068, 42073, 42074, 42076, 42077, 42079, 42081, 42082, 42083, 42086, 42087, 42088, 42089, 42090, 42092, 42093, 42095, 42096, 42099, 42100, 42101, 42102, 42103, 42104, 42107, 42109, 42110, 42111, 42112, 42114, 42115, 42116, 42117, 42119, 42120, 42121, 42122, 42123, 42124, 42125, 42126, 42127, 42128, 42130, 42131, 42132, 42133, 42134, 42135, 42136, 42137, 42138, 42141, 42143, 42144, 42145, 42147, 42150, 42152, 42153, 42161, 42162, 42165, 42169, 42170, 42171, 42172, 42173, 42175, 42176, 42177, 42178, 42179, 42180, 42182, 42183, 42184, 42185, 42186, 42187, 42189, 42190, 42191, 42192, 42195, 42196, 42197, 42198, 42199, 42201, 42203, 42204, 42205, 42206, 42209, 42210, 42213, 42214, 42215, 42216, 42218, 42220, 42221, 42222, 42224, 42228, 42229, 42230, 42231, 42232, 42233, 42234, 42236, 42237, 42238, 42239, 42240, 42241, 42242, 42243, 42244, 42245, 42247, 42249, 42251, 42252, 42253, 42254, 42256, 42257, 42258, 42260, 42261, 42262, 42263, 42264, 42265, 42266, 42267, 42271, 42272, 42273, 42274, 42275, 42277, 42278, 42279, 42280, 42282, 42283, 42284, 42285, 42286, 42287, 42288, 42289, 42291, 42292, 42293, 42294, 42298, 42299, 42300, 42303, 42305, 42307, 42309, 42313, 42314, 42315, 42318, 42319, 42321, 42322, 42326, 42328, 42330, 42331, 42332, 42333, 42334, 42337, 42338, 42339, 42342, 42343, 42345, 42347, 42348, 42349, 42350, 42352, 42353, 42354, 42355, 42356, 42358, 42359, 42360, 42361, 42362, 42363, 42364, 42365, 42367, 42368, 42369, 42370, 42378, 42380, 42381, 42383, 42384, 42385, 42386, 42389, 42390, 42392, 42393, 42396, 42398, 42399, 42400, 42401, 42403, 42404, 42407, 42409, 42412, 42413, 42416, 42419, 42420, 42421, 42422, 42423, 42425, 42426, 42428, 42429, 42432, 42435, 42436, 42437, 42438, 42439, 42440, 42442, 42444, 42445, 42446, 42448, 42451, 42452, 42453, 42454, 42455, 42457, 42458, 42459, 42463, 42464, 42466, 42469, 42490, 42491, 42492, 42493, 42494, 42495, 42496, 42499, 42500, 42502, 42504, 42505, 42506, 42507, 42508, 42510, 42512, 42520, 42522, 42525, 42528, 42530, 42531, 42543, 42545, 42546, 42547, 42548, 42549, 42552, 42553, 42554, 42555, 42556, 42557, 42558, 42559, 42560, 42561, 42563, 42565, 42570, (3) 85600, 85601, 85604, 85606, 85607, 85608, 85611, 85612, 85613, 85614, 85615, 85616, 85617, 85619, 85620, 85622, 85625, 85626, 85628, 85629, 85630, 85631, 85633, 85636, 85637, 85638, 85641, 85642, 85646, 85650, 85652, 85653, 85654, 85656, 85657, 85658, 85659, 85660, 85662, 85664, 85666, 85667, 85672, 85673, 85674, 85679, 85681, 85686, 85692, 85693, 85696, 85700, 85703, 85704, 85706, 85707, 85710, 85715, 85718, 85719, 85720, 85721, 85722, 85723, 85724, 85725, 85727, 85729, 85730, 85732, 85735, 85738, 85739, 85740, 85743, 85745, 85749;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2200-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2201-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2202-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2203-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2204-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2205-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2206-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2207-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2208-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2209-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2210-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2211-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2212-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2213-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2214-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2215-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2216-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2217-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2218-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.