Ingenia recallZ-3236-2026 · Philips North America Llc · initiated Aug 21, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
On August 24, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: " To prevent this issue from occurring, o Use the standard 3D Vane scan protocol from the Philips Examcard Database, or o For custom 3D Vane scan protocols, use a maximum of 480 for the reconstruction matrix and use a maximum of 167 for the number of slices. " You may continue to use affected systems in accordance with their intended use. " Circulate this notice to all users or new owners of this device so that they are aware of the issues and associated hazard/harm. " Please retain this Urgent Medical Device letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issue (reference 2026-PD-MR-006).
Recall details
- Recall number
- Z-3236-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 21, 2026
- Posted by the FDA
- Sep 18, 2026
- Recalling firm
- Philips North America Llc
- Quantity
- 2038
- Product code
- LNH
- FDA submissions
- K183063, K193215, K213583
- Distribution
- 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;
Product description
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);
Code information (models, lots, serial numbers)
Show the full code information (15k characters)
1. Model Numbers (REF): 781315(1.5T); UDI-DI: 884838099715; Serial Numbers: 61019, 61140, 61080, 61067, 61091, 61114, 61028, 61039, 61040, 61041, 61000, 61002, 61003, 61006, 61009, 61017, 61032, 61058, 61065, 61066, 61074, 61075, 61097, 61106, 61124, 61001, 61004, 61011, 61023, 61025, 61026, 61034, 61035, 61042, 61046, 61115, 61078, 61015, 61119, 61005, 61020, 61043, 61085, 61088, 61036, 61052, 61057, 61061, 61068, 61069, 61070, 61072, 61095, 61117, 61125, 61126, 61129, 61130, 61027, 61108, 61109, 61131, 61144, 61107, 61138, 61142, 61102, 61103, 61014, 61018, 61016, 61038, 61073, 61079, 61082, 61084, 61092, 61093, 61096, 61022, 61044, 61049, 61050, 61053; 2. Model Numbers (REF): 781341(1.5T); UDI-DI: 884838055322; Serial Numbers: 87260, 70040, 70229, 70607, 70763, 84030, 84108, 84234, 84257, 84596, 87005, 87146, 70603, 70604, 70605, 70725, 70767, 70768, 70812, 70232, 70367, 70374, 70375, 70764, 70780, 84566, 84621, 84629, 84667, 87214, 87215, 70193, 70485, 70488, 70831, 70832, 70833, 70071, 70311, 84098, 84343, 84765, 70110, 70111, 70161, 70177, 70204, 70244, 70269, 70446, 70448, 70459, 70470, 70612, 70662, 70663, 70664, 70665, 70666, 70667, 70668, 70678, 70691, 70755, 70845, 70864, 70866, 70867, 70868, 70942, 70943, 70969, 84178, 84179, 84180, 84302, 84303, 84330, 84381, 84384, 84385, 84387, 84844, 84976, 87028, 87098, 87124, 87125, 87126, 87135, 87177, 87180, 87206, 87207, 87221, 87222, 87271, 87290, 87297, 84249, 84891, 70286, 70641, 70655, 70712, 70730, 70851, 84649, 84092, 84311, 84730, 84744, 84766, 84890, 84982, 84986, 87151, 87171, 87191, 70974, 70981, 70987, 70997, 84010, 84066, 84082, 84150, 84153, 84197, 84204, 84230, 84242, 84256, 84262, 84287, 84290, 84291, 84310, 84318, 84320, 84321, 84327, 84383, 84389, 84397, 84399, 84411, 84422, 84427, 84496, 84503, 84515, 84531, 84582, 84585, 84588, 84608, 84645, 84673, 84692, 84770, 84810, 84812, 84813, 84822, 84830, 84831, 84833, 84855, 84857, 84859, 84861, 84863, 84872, 84922, 84928, 84943, 84946, 84984, 84990, 84997, 87009, 87029, 87045, 87048, 87054, 87056, 87084, 87109, 87110, 87113, 87114, 87123, 87142, 87174, 87181, 87192, 87201, 87202, 87224, 87227, 87233, 87240, 87241, 87248, 87254, 87257, 87268, 87272, 87274, 87283, 87284, 87291, 87294, 87299, 87300, 87302, 87303, 87305, 87307, 87311, 87312, 87314, 87315, 87317, 87318, 87320, 87326, 87138, 84551, 70654, 84792, 87112, 84195, 70369, 70965, 70333, 70778, 84407, 84408, 84547, 84687, 70250, 70258, 84488, 87141, 84664, 70601, 87008, 70296, 70597, 70818, 70885, 70976, 70991, 84051, 84164, 84165, 84166, 84167, 84175, 84176, 84322, 84323, 84342, 84425, 84471, 84593, 84742, 87139, 87266, 84704, 84705, 70796, 84412, 70598, 84271, 84341, 84474, 84671, 84681, 84807, 84850, 84867, 84910, 84920, 84921, 87076, 70021, 70029, 70129, 70199, 70270, 70277, 70294, 70302, 70381, 70427, 70463, 70464, 70583, 70611, 70617, 70626, 70651, 70673, 70680, 70684, 70692, 70784, 70785, 70799, 70854, 70855, 70870, 70881, 70921, 70929, 70986, 70992, 70993, 84016, 84104, 84116, 84122, 84131, 84155, 84187, 84207, 84228, 84259, 84395, 84404, 84423, 84438, 84453, 84454, 84487, 84544, 84564, 84565, 84574, 84624, 84632, 84654, 84718, 84829, 84914, 84996, 87081, 87100, 87249, 87262, 84801, 84900, 84901, 70599, 70347, 70648, 70797, 84047, 84789, 87111, 70804, 84806, 70119, 70280, 70339, 70361, 70695, 70717, 70773, 70788, 70865, 70897, 70931, 70932, 70933, 70962, 70967, 84070, 84095, 84096, 84241, 84245, 84292, 84298, 84372, 84374, 84375, 84401, 84421, 84455, 84456, 84458, 84477, 84518, 84519, 84520, 84521, 84522, 84523, 84524, 84598, 84657, 84676, 84677, 84678, 84679, 84680, 84693, 84757, 84832, 84948, 84955, 87000, 87050, 87219, 87285, 87319, 84218, 70196, 70334, 70335, 70384, 70423, 70703, 70918, 70919, 84209, 84211, 84216, 84261, 84331, 84494, 84719, 84720, 87276, 87277, 87278, 87279, 87282, 87129, 87131, 87155, 87213, 87281, 70072, 70613, 70934, 70146, 70201, 70281, 70287, 70658, 84015, 87058, 70027, 70144, 70228, 70300, 70585, 70591, 70592, 70702, 70726, 70746, 70765, 70786, 70795, 70798, 70809, 70817, 70823, 70834, 70935, 70946, 70961, 84007, 84081, 84083, 84091, 84124, 84125, 84127, 84135, 84144, 84177, 84220, 84269, 84382, 84413, 84420, 84431, 84491, 84502, 84513, 84530, 84536, 84594, 84604, 84606, 84851, 84864, 84871, 84937, 84952, 84956, 84988, 84994, 84995, 87115, 87165, 87236, 70011, 70013, 70037, 70038, 70039, 70053, 70055, 70056, 70084, 70192, 70203, 70263, 70273, 70299, 70329, 70343, 70379, 70402, 70436, 70460, 70595, 70649, 70682, 70720, 70732, 70734, 70735, 70736, 70738, 70747, 70772, 70774, 70789, 70792, 70800, 70805, 70813, 70825, 70827, 70836, 70848, 70850, 70859, 70861, 70889, 70909, 70920, 70926, 70970, 84008, 84027, 84028, 84032, 84034, 84035, 84052, 84060, 84061, 84062, 84065, 84079, 84099, 84114, 84118, 84149, 84172, 84191, 84194, 84226, 84229, 84233, 84247, 84255, 84266, 84309, 84335, 84357, 84376, 84394, 84396, 84444, 84480, 84492, 84495, 84534, 84535, 84550, 84556, 84583, 84603, 84641, 84647, 84650, 84659, 84666, 84670, 84697, 84706, 84713, 84721, 84722, 84724, 84745, 84747, 84748, 84751, 84775, 84793, 84805, 84818, 84819, 84820, 84839, 84858, 84873, 84879, 84895, 84904, 84918, 84930, 84977, 87001, 87023, 87026, 87038, 87117, 87136, 87175, 87176, 87187, 87190, 87204, 87234, 87235, 87238, 87239, 87242, 87289, 87293, 84231, 84086, 84275, 84826, 84940, 87210, 70238, 70261, 70891, 84661, 84847, 87079, 84349, 84350, 84351, 84352, 84353, 84354, 84355, 84025, 84347, 70128, 70198, 70593, 84490, 87212, 84772, 84854, 87036, 87037, 84716, 70318, 87296, 70930, 84068, 70264, 70708, 70908, 84013, 84089, 84199, 84221, 84250, 84368, 84430, 84571, 84572, 84600, 84602, 84700, 84834, 84862, 84885, 84983, 84443, 84852, 70777, 70262, 70637, 70679, 70714, 70910, 70998, 84138, 84140, 84217, 84278, 84398, 70075, 70947, 70960, 84115, 84148, 84587, 84752, 87143, 87144, 70131, 70481, 70628, 70722, 84145, 70136, 84045, 84046, 70048, 70065, 70066, 70255, 70711, 87078, 87269, 70282, 84611, 70828, 84057, 84288, 84424, 70022, 70371, 70437, 70775, 70830, 84029, 84363, 84573, 84605, 84689, 87003, 87102, 70236, 70271, 84067, 84709, 84113, 84888, 70416, 70945, 84129, 87116, 70140, 70337, 70350, 70351, 70357, 70368, 70401, 70428, 70449, 70486, 70487, 70489, 70490, 70624, 70683, 70686, 70744, 70745, 70811, 70840, 70847, 70900, 70954, 70985, 84021, 84039, 84069, 84097, 84142, 84171, 84198, 84244, 84279, 84305, 84361, 84362, 84428, 84599, 84626, 84637, 84653, 84662, 84717, 84726, 84729, 84738, 84758, 84759, 84796, 84865, 84931, 84934, 84975, 84989, 87024, 87031, 87069, 87071, 87147, 87152, 87153, 87154, 87161, 87172, 87185, 87188, 87208, 87211, 87237, 87244, 87265, 87280, 70194, 70242, 70314, 70697, 70776, 70806, 70871, 70888, 84087, 84258, 84472, 84613, 84746, 84798, 84802, 87035, 87044, 87049, 87082, 87090, 87093, 70759, 70685, 70733, 70915, 84933, 70429, 70982, 84557, 70025, 70434, 70689, 70802, 84402, 84577, 84675, 70123, 70226, 70235, 70251, 70295, 70364, 70383, 70435, 70629, 70656, 70844, 70890, 70927, 70973, 84004, 84224, 84312, 84313, 84332, 84371, 84437, 84546, 84554, 84576, 84584, 84592, 84663, 84740, 84773, 84774, 84896, 87004, 87034, 87039, 87119, 87134, 87253, 70026, 70952, 84470, 70074, 70114, 70306, 70623, 70754, 70869, 84084, 84268, 84315, 87027, 70058, 70426, 70468, 70791, 70849, 84036, 84037, 84616, 84633, 84651, 84827, 84828, 84868, 87226, 70230, 84206, 84214, 84308, 84416, 84479, 84482, 84558, 84620, 84656, 84808, 84809, 84848, 70356, 70358, 70359, 70677, 70057, 70080, 70087, 70097, 70157, 70610, 70693, 70810, 84002, 84003, 84074, 84237, 84239, 84338, 84339, 84367, 84483, 84767, 84849, 84913, 84915, 84960, 84969, 87022, 87086, 87087, 87094, 87095, 87158, 87163, 87259, 70239, 87209, 70085, 70160, 70246, 70348, 70349, 70407, 70723, 70873, 70917, 87101, 70148, 70191, 70297, 70301, 70316, 70440, 70453, 70465, 70482, 70587, 70608, 70770, 70843, 70872, 70887, 70899, 70906, 70914, 70994, 84005, 84038, 84137, 84154, 84208, 84210, 84252, 84293, 84297, 84306, 84325, 84334, 84346.84377, 84406, 84445, 84690, 84838, 84869, 87083, 87194, 70044, 70049, 70052, 70063, 70076, 70095, 70156, 70190, 70200, 70233, 70292, 70298, 70308, 70312, 70321, 70328, 70403, 70451, 70455, 70606, 70614, 70621, 70627, 70636, 70646, 70650, 70675, 70676, 70694, 70698, 70699, 70700, 70706, 70709, 70719, 70727, 70729, 70752, 70762, 70771, 70779, 70783, 70808, 70819, 70835, 70857, 70863, 70874, 70892, 70893, 70894, 70898, 70903, 70911, 70939, 70951, 70972, 84012, 84026, 84043, 84063, 84075, 84077, 84088, 84134, 84147, 84157, 84168, 84170, 84173, 84174, 84189, 84196, 84200, 84225, 84264, 84274, 84280, 84282, 84283, 84286, 84314, 84316, 84340, 84344, 84400, 84410, 84432, 84434, 84439, 84440, 84441, 84446, 84460, 84462, 84469, 84475, 84481, 84484, 84485, 84498, 84499, 84505, 84506, 84508, 84509, 84514, 84526, 84537, 84538, 84552, 84614, 84627, 84644, 84646, 84674, 84734, 84741, 84791, 84799, 84811, 84816, 84821, 84823, 84824, 84836, 84866, 84889, 84894, 84911, 84929, 84935, 84942, 84970, 84973, 84993, 87017, 87019, 87043, 87055, 87057, 87097, 87103, 87120, 87132, 87133, 87218, 87231, 87245, 70179, 70883, 84251, 84284, 84776, 84777, 84778, 84779, 84780, 84781, 84782, 84783, 70657, 70154, 70710, 87232, 87247; 3. Model Numbers (REF): 781396(1.5T); UDI-DI: 884838009820; Serial Numbers: 41175, 41176, 41007, 41039, 41127, 41157, 41256, 41350, 41132, 41186, 41230, 41268, 41359, 41441, 41521, 41584, 41204, 41449, 41151, 41518, 41524, 41610, 41615, 41617, 41618, 41619, 41509, 41591, 41045, 41108, 41180, 41314, 41366, 41397, 41486, 41519, 41436, 41070, 41351, 41010, 41016, 41029, 41052, 41071, 41084, 41112, 41125, 41131, 41141, 41142, 41160, 41178, 41192, 41210, 41211, 41228, 41240, 41283, 41335, 41338, 41368, 41380, 41381, 41388, 41389, 41395, 41417, 41442, 41454, 41473, 41538, 41540, 41561, 41009, 41050, 41113, 41272, 41480, 41087, 41093, 41096, 41129, 41163, 41184, 41193, 41213, 41217, 41220, 41246, 41257, 41267, 41352, 41365, 41399, 41494, 41502, 41522, 41545, 41049, 41060, 41068, 41074, 41106, 41117, 41124, 41126, 41128, 41133, 41136, 41153, 41243, 41280, 41292, 41298, 41299, 41357, 41408, 41435, 41437, 41452, 41493, 41496, 41507, 41513, 41543, 41544, 41549, 41558, 41559, 41565, 41570, 41571, 41115, 41405, 41560, 41020, 41169, 41188, 41293, 41458, 41466, 41467, 41474, 41013, 41100, 41140, 41190, 41214, 41249, 41301, 41450, 41461, 41304, 41075, 41562, 41164, 41219, 41296, 41331, 41394, 41111, 41594, 41407, 41476, 41477, 41479, 41003, 41162, 41172, 41185, 41191, 41254, 41255, 41498, 41515, 41138, 41259, 41440, 41531, 41329, 41478, 41146, 41318, 41355, 41371, 41376, 41423, 41453, 41548, 41000, 41006, 41015, 41021, 41022, 41028, 41035, 41037, 41044, 41048, 41057, 41059, 41066, 41067, 41077, 41083, 41092, 41094, 41095, 41097, 41098, 41134, 41148, 41149, 41154, 41158, 41166, 41171, 41195, 41197, 41198, 41203, 41205, 41206, 41208, 41209, 41212, 41221, 41222, 41237, 41250, 41251, 41260, 41265, 41278, 41290, 41294, 41305, 41313, 41358, 41406, 41409, 41415, 41418, 41420, 41421, 41426, 41429, 41463, 41481, 41482, 41495, 41511, 41512, 41514, 41517, 41525, 41532, 41551, 41552, 41555, 41569, 41580, 41224, 41238, 41319, 41526, 41118; 4. Model Numbers (REF): 782101(1.5T); UDI-DI: 884838098275; Serial Numbers: 87602, 87644, 87645, 87648, 87649, 87653, 87601, 87605, 87298, 87607, 87608, 87609, 87610, 87612, 87613, 87614, 87617, 87627, 87631, 87632, 87633, 87634, 87635, 87636, 87638, 87639, 87640, 87641, 87642, 87643, 87654, 87655; 5. Model Numbers (REF): 782115(1.5T); UDI-DI: 884838099043; Serial Numbers: 61250, 61281, 61361, 61362, 61363, 61364, 61365, 61366, 61367, 61368, 61369, 61370, 61371, 61372, 61373, 61374, 61375, 61376, 61377, 61213, 61214, 61280, 61299, 61341, 61292, 61358, 61385, 61266, 61201, 61210, 61212, 61217, 61227, 61350, 61403, 61417, 61264, 61273, 61192, 61193, 61246, 61206, 61208, 61219, 61248, 61249, 61265, 61269, 61328, 61337, 61257, 61425, 61303, 61306, 61316, 61320, 61321, 61348, 61349, 61354, 61355, 61356, 61357, 61360, 61378, 61404, 61419, 61420, 61421, 61332, 61175, 61181, 61182, 61183, 61188, 61199, 61200, 61204, 61218, 61220, 61224, 61268, 61270, 61289, 61295, 61300, 61334, 61338, 61390, 61393, 61394, 61395, 61396, 61397, 61398, 61400, 61408, 61409, 61410, 61411, 61413, 61422, 61428, 61177, 61180, 61184, 61185, 61187, 61189, 61191, 61205, 61209, 61221, 61222, 61225, 61229, 61230, 61237, 61243, 61245, 61253, 61262, 61263, 61275, 61279, 61313, 61314, 61315, 61336, 61288, 61352, 61416, 61179, 61258, 61359, 61304, 61380, 61145, 61196, 61381, 61426, 61407, 61415, 61427, 61232, 61223, 61298, 61195, 61226, 61351, 61333, 61339, 61252, 61234, 61203, 61235, 61329, 61241, 61326, 61327, 61176, 61198, 61202, 61211, 61240, 61256, 61283, 61285, 61290, 61293, 61294, 61302, 61406, 61207, 61233, 61242, 61282, 61331, 61342, 61383, 61384, 61310, 61311, 61312, 61259, 61260; 6. Model Numbers (REF): 782140(1.5T); UDI-DI: 884838108646; Serial Numbers: 45607, 45606, 45608, 45609, 45610, 45601; 7. Model Numbers (REF): 781261(1.5T CX); UDI-DI: 884838068445; Serial Numbers: 77008, 77000, 77004, 77001, 77019, 77010, 77014, 77007, 77016; 8. Model Numbers (REF): 781262(1.5T CX); UDI-DI: 884838068445; Serial Numbers: 77131, 77070, 77124, 77144, 77172, 77074, 77048, 77178, 77031, 77134, 77050, 77051, 77060, 77194, 77034, 77037, 77038, 77057, 77072, 77075, 77078, 77084, 77085, 77086, 77092, 77101, 77110, 77156, 77157, 77111, 77119, 77167, 77183, 77185, 77187, 77188, 77195, 77196, 77198, 77199, 77202, 77052, 77053, 77054, 77055, 77056, 77064, 77065, 77066, 77067, 77068, 77069, 77105, 77125, 77126, 77135, 77136, 77137, 77138, 77139, 77148, 77141, 77030, 77032, 77033, 77036, 77042, 77043, 77044, 77049, 77059, 77061, 77071, 77083, 77087, 77088, 77090, 77091, 77093, 77097, 77100, 77106, 77107, 77115, 77118, 77120, 77121, 77128, 77155, 77161, 77162, 77190, 77140, 77201, 77166, 77045, 77063, 77109, 77117, 77123, 77147, 77113, 77168, 77169, 77122, 77154, 77046, 77130, 77062, 77039, 77040, 77114, 77127, 77160, 77150, 77041, 77193, 77203; 9. Model Numbers (REF): 781347(1.5T S); UDI-DI: 884838068421; Serial Numbers: 81003, 81050, 81051, 81090, 81111, 81151, 81010, 81028, 81030, 81035, 81063, 81106, 81093, 81105, 81116, 81004, 81009, 81011, 81017, 81018, 81019, 81020, 81023, 81024, 81031, 81037, 81041, 81055, 81056, 81060, 81064, 81070, 81074, 81078, 81112, 81115, 81118, 81122, 81138, 81139, 81140, 81146, 81147, 81153, 81156, 81158, 81175, 81184, 81013, 81044, 81005, 81007, 81040, 81047, 81059, 81167, 81170, 81171, 81008, 81108, 81148, 81133, 81164, 81001, 81026, 81086, 81079, 81014, 81061, 81065, 81085, 81091, 81092, 81032, 81043, 81129, 81131, 81149, 81155, 81162, 81165, 81172, 81084, 81087, 81088, 81094, 81095, 81127, 81132, 81174, 81157, 81176, 81071, 81052, 81067, 81038, 81179, 81185, 81117, 81173, 81154, 81025, 81097, 81045, 81075, 81076, 81077, 81096, 81114, 81124, 81126, 81145, 81159, 81152, 81029, 81034, 81042, 81049, 81058, 81080, 81113, 81123, 81128, 81137, 81178;
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- Ingenia Ingenia 1.5TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance spectroscopic10 recalls24 reports
- Ingenia Ingenia 1.5TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging9 recalls3 reports
- Ingenia Ingenia 1.5TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging8 recalls14 reports
- Ingenia 1.5T CX 781262Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance spectroscopic8 recalls9 reports
- Ingenia Ingenia 1.5TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging8 recalls1 report
- Ingenia 1.5T S 781347Philips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging7 recalls1 report
- Ingenia Ingenia 1.5TPhilips Medical Systems Nederland B.V. · System, nuclear magnetic resonance imaging6 recalls0 reports
- Ingenia Ingenia 1.5TPhilips Medical Systems Nederland B.V. · System, Nuclear Magnetic Resonance Imaging6 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99769).
- Z-3232-2026 · Open, ClassifiedAchieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion),…
- Z-3235-2026 · Open, ClassifiedEvolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
- Z-3237-2026 · Open, ClassifiedIngenia 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);
- Z-3238-2026 · Open, ClassifiedIngenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
- Z-3239-2026 · Open, ClassifiedIngenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
- Z-3240-2026 · Open, ClassifiedName (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Du…
- Z-3241-2026 · Open, ClassifiedMR 5300 Model Number (REF): 1. 782110, 2. 782152;
- Z-3242-2026 · Open, ClassifiedMR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
- Z-3243-2026 · Open, ClassifiedSmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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