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 S, 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

Lot, batch or date codesModel Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; UDI-DI: (1) 00884838090057, (2) 00884838098343, (3) None, (4) 00884838108639; Serial Numbers: (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;

Quantity recalled611 units

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-2208-2025
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 S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;

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.

Nationwide Georgia

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) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139; UDI-DI: (1) 00884838090057, (2) 00884838098343, (3) None, (4) 00884838108639; Serial Numbers: (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;

Where was it sold?

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 97172

This product is part of a recall event; the main page for the event is Ingenia Elition recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025	CLASS II	Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	SmartPath to dStream for 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Ingenia 1.5T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Ingenia 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	MR 5300 Model Numbers (REF): (1) 782110, (2) recalled	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Achieva 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Ingenia 3.0T CX recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Achieva XR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	SmartPath to Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Evolution Upgrade 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Evolution Upgrade 1.5T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Intera 3.0T Quasar Dual recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Ingenia 1.5T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	MR 7700 Model Numbers (REF): (1) 782120, (2) recalled	Philips North America	Device Malfunction	Nationwide
6 Aug 2025	CLASS II	Ingenia Ambition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

More recalls from Philips North America

All 558

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Elition S and Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Blue Seal SE and Blue Seal XE recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide