CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Ingenia Ambition recalled by Philips North America
Philips North America is recalling Ingenia Ambition X, distributed nationwide in the US. The recall was initiated on 30 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2209-2025
- FDA event ID
- 97172
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2025
- FDA classified
- 30 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 30 Jun 2025 | Recall initiated by company | |
| 30 Jul 2025 | Classified by FDA | +30 days |
| 6 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138; UDI-DI: (1) 00884838090040, (2) 00884838098350, (3) 00884838108622; Serial Numbers: (1) 47000, 47001, 47002, 47003, 47004, 47006, 47007, 47009, 47011, 47012, 47013, 47014, 47015, 47016, 47017, 47018, 47019, 47020, 47021, 47022, 47023, 47024, 47025, 47026, 47027, 47028, 47029, 47030, 47032, 47033, 47034, 47035, 47037, 47038, 47039, 47040, 47041, 47043, 47044, 47045, 47047, 47048, 47049, 47050, 47051, 47052, 47053, 47054, 47056, 47057, 47058, 47059, 47060, 47061, 47062, 47063, 47064, 47065, 47066, 47067, 47068, 47070, 47071, 47072, 47074, 47075, 47077, 47078, 47080, 47081, 47082, 47083, 47084, 47085, 47088, 47089, 47090, 47091, 47092, 47093, 47094, 47095, 47096, 47097, 47098, 47099, 47173, 47174, 47175, 47176, 47177, 47183, 47184, 47185, 47187, 47188, 47189, 47190, 47192, 47193, 47194, 47195, 47196, 47197, 47198, 47199, 47200, 47202, 47203, 47204, 47205, 47206, 47207, 47208, 47209, 47210, 47211, 47215, 47216, 47219, 47220, 47221, 47222, 47225, 47226, 47227, 47230, 47231, 47233, 47237, 47242, 47244, 47245, 47248, 47251, 47252, 47253, 47254, 47255, 47258, 47260, 47262, 47264, 47268, 47269, 47270, 47271, 47272, 47274, 47275, 47276, 47278, 47279, 47280, 47281, 47282, 47283, 47284, 47286, 47288, 47289, 47290, 47291, 47292, 47294, 47297, 47298, 47299, 47301, 47302, 47303, 47304, 47305, 47306, 47307, 47309, 47310, 47311, 47312, 47313, 47314, 47315, 47316, 47322, 47323, 47324, 47325, 47328, 47329, 47330, 47331, 47332, 47333, 47335, 47336, 47337, 47338, 47339, 47340, 47341, 47342, 47344, 47345, 47346, 47347, 47348, 47350, 47351, 47352, 47353, 47356, 47357, 47361, 47364, 47365, 47367, 47370, 47371, 47372, 47377, 47378, 47380, 47382, 47384, 47385, 47387, 47506, (2) 47500, 47502, 47503, 47504, 47505, 47507, 47508, 47509, 47511, 47512, 47513, 47514, 47516, 47517, 47519, 47520, 47521, 47522, 47523, 47525, 47526, 47527, 47528, 47529, 47530, 47531, 47532, 47533, 47534, 47535, 47536, 47538, 47539, 47540, 47541, 47542, 47543, 47545, 47546, 47547, 47548, 47549, 47550, 47552, 47553, 47554, 47555, 47557, 47558, 47559, 47560, 47561, 47562, 47563, 47564, 47565, 47566, 47567, 47568, 47569, 47570, 47572, 47574, 47575, 47576, 47577, 47578, 47579, 47580, 47582, 47583, 47584, 47585, 47588, 47589, 47590, 47591, 47594, 47595, 47596, 47597, 47598, 47599, 47602, 47603, 47606, 47607, 47608, 47609, 47610, 47612, 47614, 47615, 47617, 47621, 47622, 47623, 47625, 47626, 47627, 47628, 47629, 47630, 47632, 47634, 47635, 47640, 47642, 47644, 47646, 47648, 47649, 47651, 47652, 47653, 47654, 47656, 47657, 47659, 47660, 47661, 47662, 47663, 47665, 47666, 47667, 47668, 47669, 47671, 47672, 47674, 47675, 47676, 47677, 47678, 47679, 47680, 47681, 47682, 47683, 47684, 47685, 47687, 47688, 47689, 47692, 47693, 47694, 47695, 47696, 47697, 47698, 47699, 47700, 47701, 47702, 47703, 47705, 47706, 47708, 47709, 47710, 47711, 47713, 47714, 47716, 47717, 47718, 47719, 47720, 47721, 47722, 47723, 47724, 47725, 47726, 47727, 47728, 47729, 47730, 47731, 47732, 47733, 47737, 47738, 47739, 47740, 47742, 47747, 47748, 47750, 47751, 47752, 47753, 47754, 47755, 47759, 47760, 47761, 47762, 47763, 47765, 47766, 47767, 47768, 47770, 47771, 47773, 47778, 47779, 47780, 47781, 47782, 47783, 47784, 47785, 47786, 47788, 47789, 47790, 47791, 47792, 47794, 47795, 47796, 47797, 47798, 47799, 47800, 47801, 47802, 47804, 47806, 47807, 47808, 47809, 47810, 47811, 47812, 47813, 47814, 47815, 47816, 47817, 47818, 47819, 47820, 47822, 47823, 47824, 47826, 47831, 47834, 47835, 47839, 47841, 47843, 47844, 47845, 47846, 47847, 47848, 47849, 47850, 47851, 47853, 47854, 47855, 47858, 47859, 47860, 47861, 47862, 47863, 47864, 47865, 47866, 47867, 47868, 47869, 47870, 47874, 47876, 47877, 47878, 47879, 47881, 47882, 47883, 47884, 47885, 47886, 47887, 47888, 47889, 47891, 47892, 47893, 47894, 47896, 47899, 47900, 47901, 47902, 47903, 47904, 47905, 47906, 47907, 47909, 47910, 47912, 47914, 47919, 47921, 47923, 47928, 47929, 47931, 47932, 47936, 47937, (3) 49000, 49001, 49002, 49003, 49004, 49008, 49009, 49010, 49013, 49014, 49015, 49017, 49019, 49020, 49021, 49025, 49026, 49027, 49029, 49031, 49033, 49034, 49036, 49043, 49044, 49045, 49047, 49048, 49049, 49052, 49053, 49054, 49056, 49057, 49058, 49060, 49062, 49063, 49064, 49066, 49067, 49068, 49069, 49070, 49071, 49072, 49073, 49075, 49076, 49077, 49078, 49079, 49080, 49081, 49086, 49087, 49088, 49089, 49090, 49091, 49092, 49093, 49094, 49095, 49096, 49097, 49098, 49099, 49100, 49101, 49102, 49103, 49104, 49105, 49106, 49107, 49108, 49109, 49110, 49111, 49113, 49114, 49115, 49116, 49117, 49118, 49119, 49121, 49124, 49128, 49129, 49130, 49131, 49134, 49136, 49140, 49144, 49145, 49146, 49147, 49148, 49152, 49153, 49154, 49155, 49156, 49157, 49158, 49160, 49161, 49162, 49163, 49164, 49165, 49166, 49168, 49171, 49172, 49178, 49179, 49180, 49181, 49182, 49183, 49184, 49185, 49186, 49197, 49203, 49204, 49205, 49211, 49212, 49215, 49217, 49222, 49223, 49226, 49227, 49231, 49232;
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 97172This product is part of a recall event; the main page for the event is Ingenia Elition recalled by Philips North America.
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