Z-3237-2026 Class II Ongoing
FDA device recall Z-3237-2026 was initiated by Philips North America Llc on Aug 21, 2026 and is designated Class II. Reason for recall: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system me… The recall status is ongoing. Affected quantity: 922.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 922
Product Description
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
Reason for Recall
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;
Code Information
1. Model Numbers (REF): 781359(S); UDI-DI: 884838090057; Serial Numbers: 48053, 48126, 48136, 48144, 48020, 48030, 48155, 48191, 48216, 48218, 48245, 48300, 48183, 48186, 48187, 48222, 48225, 48234, 48240, 48241, 48249, 48269, 48278, 48284, 48288, 48293, 48294, 48299, 48304, 48313, 48317, 48326, 48331, 48051, 48223, 48207, 48028, 48031, 48049, 48050, 48131, 48134, 48242, 48254, 48219, 48000, 48004, 48019, 48032, 48132, 48135, 48145, 48160, 48224, 48244, 48040, 48122, 48039, 48022, 48152, 48012, 48014, 48036, 48037, 48044, 48127, 48151, 48158, 48174, 48184, 48046, 48047, 48055, 48128, 48129, 48153, 48190, 48192, 48194, 48226, 48275, 48181, 48198, 48199, 48200, 48033, 48045, 48001, 48038, 48185, 48238, 48239, 48276, 48010, 48170, 48035, 48172, 48027, 48248, 48146, 48147, 48148, 48163, 48164, 48165, 48169, 48182, 48188, 48271, 48290, 48291, 48297, 48302, 48303, 48308, 48309, 48310, 48321, 48325, 48329, 48337, 48018, 48283, 48177, 48017, 48056, 48250, 48272, 48253, 48268, 48026, 48013, 48052, 48112, 48120, 48130, 48162, 48171, 48179, 48214, 48217, 48233, 48237, 48243, 48252, 48273, 48274, 48286, 48287, 48314, 48322, 48133, 48316; 2. Model Numbers (REF): 782108(S); UDI-DI: 884838098343; Serial Numbers: 48572, 48627, 48581, 48687, 48592, 48652, 48800, 48953, 48544, 48506, 48520, 48521, 48534, 48551, 48781, 48834, 48842, 48843, 48848, 48892, 48712, 48714, 48715, 48810, 48813, 48833, 48883, 48885, 48943, 48947, 48538, 48539, 48556, 48602, 48640, 48808, 48613, 48650, 48502, 48507, 48514, 48540, 48577, 48579, 48580, 48590, 48591, 48612, 48614, 48617, 48620, 48628, 48632, 48638, 48692, 48697, 48698, 48721, 48765, 48818, 48819, 48824, 48503, 48557, 48570, 48595, 48606, 48651, 48706, 48707, 48725, 48729, 48744, 48756, 48773, 48796, 48804, 48815, 48861, 48876, 48898, 48695, 48660, 48734, 48877, 48878, 48879, 48679, 48889, 48529, 48609, 48622, 48658, 48659, 48769, 48774, 48837, 48857, 48864, 48574, 48900, 48541, 48549, 48710, 48865, 48504, 48508, 48513, 48524, 48536, 48537, 48555, 48560, 48571, 48573, 48585, 48593, 48594, 48596, 48597, 48600, 48611, 48624, 48639, 48642, 48644, 48666, 48711, 48762, 48768, 48775, 48778, 48891, 48950, 48522, 48561, 48668, 48686, 48737, 48846, 48852, 48887, 48607, 48519, 48680, 48699, 48738, 48820, 48845, 48860, 48867, 48868, 48869, 48870, 48901, 48942, 48948, 48951, 48958, 48962, 48532, 48533, 48505, 48567, 48671, 48672, 48676, 48801, 48604, 48851, 48515, 48584, 48886, 48674, 48753, 48754, 48782, 48783, 48784, 48785, 48789, 48790, 48791, 48793, 48794, 48807, 48875, 48902, 48945, 48941, 48961, 48550, 48647, 48850, 48610, 48615, 48654, 48728, 48685, 48817, 48500, 48635, 48523, 48535, 48546, 48552, 48562, 48578, 48589, 48645, 48646, 48648, 48649, 48655, 48656, 48665, 48669, 48675, 48700, 48708, 48719, 48748, 48749, 48826, 48827, 48828, 48832, 48855, 48872, 48874, 48888, 48907, 48973, 48661, 48662, 48663, 48724, 48693, 48884, 48525, 48526, 48978; 3. Model Numbers (REF): 782139(S); UDI-DI: 884838108639; Serial Numbers: 29021, 29038, 29000, 29008, 29010, 29011, 29012, 29014, 29016, 29022, 29039, 29040, 29045, 29052, 29072, 29096, 29097, 29105, 29108, 29127, 29130, 29131, 29081, 29090, 29095, 29151, 29054, 29069, 29078, 29115, 29053, 29118, 29139, 29140, 29003, 29015, 29020, 29028, 29033, 29143, 29169, 29013, 29138, 29144, 29062, 29076, 29079, 29126, 29132, 29137, 29153, 29155, 29157, 29158, 29164, 29136, 29150, 29160, 29068, 29070, 29165, 29120, 29057, 29047, 29049, 29133, 29134, 29042, 29043, 29055, 29065, 29122; 4. Model Numbers (REF): 781356(X); UDI-DI: 884838090040; Serial Numbers: 47194, 47040, 47091, 47345, 47361, 47050, 47209, 47254, 47275, 47049, 47357, 47013, 47014, 47015, 47053, 47065, 47082, 47000, 47002, 47017, 47024, 47035, 47047, 47056, 47058, 47074, 47078, 47089, 47192, 47225, 47337, 47226, 47227, 47341, 47307, 47364, 47365, 47372, 47284, 47350, 47057, 47075, 47088, 47174, 47175, 47193, 47052, 47085, 47262, 47328, 47342, 47384, 47064, 47244, 47219, 47220, 47298, 47247, 47329, 47096, 47207, 47283, 47190, 47264, 47034, 47202, 47315, 47332, 47367, 47385, 47016, 47269, 47382, 47352, 47021, 47001, 47032, 47041, 47248, 47255, 47311, 47272, 47306, 47077, 47009, 47080, 47083, 47242, 47245, 47302, 47310, 47312, 47006, 47007, 47011, 47018, 47022, 47025, 47028, 47033, 47044, 47045, 47054, 47060, 47061, 47062, 47066, 47071, 47084, 47090, 47093, 47095, 47176, 47183, 47185, 47196, 47198, 47203, 47204, 47205, 47208, 47210, 47216, 47251, 47280, 47291, 47316, 47323, 47324, 47325, 47330, 47331, 47333, 47335, 47336, 47338, 47339, 47340, 47346, 47370, 47377, 47378, 47380, 47387; 5. Model Numbers (REF): 782109(X); UDI-DI: 884838098350; Serial Numbers: 47531, 47540, 47877, 47878, 47879, 47869, 47519, 47526, 47555, 47584, 47839, 47565, 47644, 47742, 47585, 47582, 47755, 47903, 47928, 47935, 47940, 47713, 47946, 47947, 47944, 47507, 47508, 47610, 47900, 47901, 47527, 47529, 47545, 47640, 47725, 47778, 47855, 47858, 47870, 47532, 47533, 47547, 47548, 47591, 47831, 47843, 47882, 47607, 47583, 47625, 47626, 47627, 47628, 47629, 47630, 47675, 47676, 47786, 47850, 47854, 47868, 47921, 47933, 47509, 47525, 47765, 47902, 47908, 47919, 47504, 47579, 47683, 47688, 47737, 47784, 47808, 47809, 47810, 47822, 47826, 47837, 47846, 47847, 47887, 47905, 47909, 47910, 47936, 47938, 47939, 47511, 47536, 47543, 47561, 47562, 47564, 47646, 47671, 47681, 47694, 47698, 47750, 47603, 47705, 47578, 47819, 47516, 47841, 47907, 47954, 47955, 47956, 47957, 47958, 47959, 47937, 47518, 47716, 47754, 47782, 47783, 47689, 47853, 47952, 47953, 47656, 47867, 47912, 47914, 47798, 47948, 47665, 47557, 47834, 47550, 47513, 47602, 47528, 47768, 47770, 47773, 47804, 47860, 47883, 47889, 47785, 47791, 47934, 47635, 47788, 47906, 47923, 47696, 47747, 47806, 47865, 47535, 47614, 47617, 47651, 47652, 47660, 47661, 47662, 47663, 47718, 47720, 47721, 47727, 47728, 47729, 47730, 47731, 47779, 47851, 47560, 47546, 47563, 47697, 47797, 47811, 47845, 47904, 47566, 47597, 47679, 47695, 47753, 47577, 47701, 47738, 47514, 47632, 47792, 47538, 47554, 47574, 47575, 47576, 47621, 47642, 47659, 47672, 47739, 47740, 47759, 47763, 47771, 47794, 47799, 47802, 47813, 47814, 47823, 47835, 47859, 47861, 47888, 47891, 47896, 47929, 47931, 47950; 6. Model Numbers (REF): 782138(X); UDI-DI: 884838108622; Serial Numbers: 49004, 49049, 49106, 49136, 49063, 49075, 49183, 49197, 49246, 49269, 49272, 49020, 49021, 49022, 49027, 49029, 49030, 49031, 49033, 49034, 49036, 49037, 49038, 49039, 49043, 49055, 49060, 49068, 49069, 49140, 49189, 49190, 49191, 49192, 49194, 49195, 49196, 49202, 49203, 49219, 49221, 49223, 49230, 49251, 49254, 49255, 49045, 49058, 49071, 49130, 49153, 49158, 49180, 49181, 49270, 49145, 49161, 49168, 49156, 49228, 49047, 49098, 49099, 49147, 49148, 49154, 49220, 49222, 49232, 49268, 49206, 49290, 49008, 49009, 49092, 49093, 49094, 49146, 49072, 49080, 49087, 49104, 49105, 49109, 49173, 49210, 49231, 49233;