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RecallWatchMedical Device Safety
Class IIOngoingZ-2208-2025

Philips North America recalls Ingenia Ambition S Model Numbers (REF): (1) 781359

Philips North AmericaCambridge, MA, United StatesReported Aug 6, 2025 · 11 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

Lot / code information

REF
): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139
UDI
(1) 00884838090057, (2) 00884838098343, (3) None, (4) 00884838108639
Serial #
(1) 48000, 48001, 48003, 48004, 48005, 48009 — +605 moreShow all
(1) 48000, 48001, 48003, 48004, 48005, 48009, 48010, 48011, 48012, 48013, 48014, 48015, 48016, 48017, 48018, 48019, 48020, 48022, 48023, 48026, 48027, 48028, 48030, 48031, 48032, 48033, 48034, 48035, 48036, 48037, 48038, 48039, 48040, 48043, 48044, 48045, 48046, 48047, 48049, 48050, 48051, 48052, 48053, 48055, 48056, 48112, 48120, 48122, 48126, 48127, 48128, 48129, 48130, 48131, 48132, 48133, 48134, 48135, 48136, 48144, 48145, 48146, 48147, 48148, 48151, 48152, 48153, 48154, 48155, 48158, 48160, 48162, 48163, 48164, 48165, 48166, 48167, 48169, 48170, 48171, 48172, 48173, 48174, 48177, 48178, 48179, 48180, 48181, 48182, 48183, 48184, 48185, 48186, 48187, 48188, 48190, 48191, 48192, 48194, 48196, 48198, 48199, 48200, 48207, 48214, 48216, 48217, 48218, 48219, 48222, 48223, 48224, 48225, 48226, 48233, 48234, 48236, 48237, 48238, 48239, 48240, 48241, 48242, 48243, 48244, 48245, 48248, 48249, 48250, 48252, 48253, 48254, 48268, 48269, 48271, 48272, 48273, 48274, 48275, 48276, 48278, 48283, 48284, 48285, 48286, 48287, 48288, 48290, 48291, 48293, 48294, 48297, 48299, 48300, 48302, 48303, 48304, 48308, 48309, 48310, 48313, 48314, 48316, 48317, 48321, 48322, 48325, 48326, 48329, 48331, 48337, (2) 48500, 48501, 48502, 48503, 48504, 48505, 48506, 48507, 48508, 48510, 48512, 48513, 48514, 48515, 48519, 48520, 48521, 48522, 48523, 48524, 48525, 48526, 48529, 48530, 48532, 48533, 48534, 48535, 48536, 48537, 48538, 48539, 48540, 48541, 48544, 48546, 48548, 48549, 48550, 48551, 48552, 48554, 48555, 48556, 48557, 48558, 48560, 48561, 48562, 48564, 48566, 48567, 48568, 48569, 48570, 48571, 48572, 48573, 48574, 48576, 48577, 48578, 48579, 48580, 48581, 48582, 48584, 48585, 48586, 48588, 48589, 48590, 48591, 48592, 48593, 48594, 48595, 48596, 48597, 48600, 48602, 48604, 48606, 48607, 48608, 48609, 48610, 48611, 48612, 48613, 48614, 48615, 48616, 48617, 48620, 48621, 48622, 48624, 48627, 48628, 48632, 48635, 48638, 48639, 48640, 48641, 48642, 48644, 48645, 48646, 48647, 48648, 48649, 48650, 48651, 48652, 48653, 48654, 48655, 48656, 48658, 48659, 48660, 48661, 48662, 48663, 48664, 48665, 48666, 48667, 48668, 48669, 48671, 48672, 48673, 48674, 48675, 48676, 48679, 48680, 48685, 48686, 48687, 48688, 48692, 48693, 48694, 48695, 48696, 48697, 48698, 48699, 48700, 48706, 48707, 48708, 48710, 48711, 48712, 48714, 48715, 48718, 48719, 48721, 48724, 48725, 48726, 48728, 48729, 48734, 48737, 48738, 48744, 48746, 48748, 48749, 48751, 48753, 48754, 48756, 48762, 48763, 48765, 48768, 48769, 48773, 48774, 48775, 48778, 48781, 48782, 48783, 48784, 48785, 48790, 48791, 48793, 48794, 48800, 48801, 48804, 48806, 48807, 48810, 48813, 48814, 48817, 48818, 48819, 48820, 48824, 48826, 48827, 48828, 48831, 48833, 48834, 48837, 48842, 48843, 48845, 48846, 48847, 48848, 48850, 48851, 48852, 48854, 48855, 48857, 48860, 48861, 48864, 48867, 48868, 48869, 48870, 48872, 48874, 48875, 48876, 48877, 48878, 48879, 48882, 48883, 48884, 48885, 48886, 48887, 48888, 48889, 48891, 48892, 48893, 48895, 48896, 48897, 48898, 48900, 48901, 48902, 48903, 48907, 48908, 48909, 48912, 48914, 48915, 48917, 48918, 48919, 48921, 48922, 48925, 48926, 48927, 48928, 48929, 48931, 48932, 48933, 48935, 48936, 48939, 48940, 48941, 48942, 48943, 48945, 48947, 48948, 48951, 48953, (3) 27500, 27502, 27504, 27505, 27506, 27507, 27508, 27509, 27511, 27512, 27514, 27515, 27516, 27517, 27518, 27519, 27520, 27521, 27522, 27523, 27524, 27525, 27526, 27527, 27528, 27529, 27530, 27531, 27532, 27533, 27534, 27535, 27536, 27537, 27538, 27539, 27541, 27542, 27543, 27544, 27545, 27547, 27548, 27551, 27552, 27553, 27554, 27555, 27556, 27558, 27560, 27566, 27567, 27568, 27570, 27571, 27572, 27573, 27574, 27575, 27576, 27579, 27580, 27581, (4) 29000, 29003, 29005, 29006, 29008, 29009, 29010, 29011, 29012, 29013, 29014, 29015, 29016, 29017, 29018, 29019, 29020, 29021, 29022, 29023, 29025, 29026, 29027, 29028, 29029, 29030, 29031, 29032, 29033, 29034, 29035, 29038, 29039, 29040, 29041, 29042, 29043, 29044, 29045, 29046, 29047, 29048, 29049, 29050, 29052, 29053, 29054, 29055, 29057, 29058, 29060, 29062, 29063, 29064, 29065, 29066, 29067, 29068, 29069, 29070, 29071, 29072, 29076, 29078, 29079, 29081, 29083, 29084, 29085, 29086, 29088, 29089, 29090, 29091, 29093, 29104, 29105, 29106, 29108, 29112, 29120, 29122

What the firm is doing

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

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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