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Class IIOngoing

Philips North America Llc recalls 12 products

Recall date · record updated Sep 30, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Philips North America Llc
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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;
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99769…

Products (12)

  1. Achieva 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), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);

    Codes/lots: 1. Model Numbers (REF): 781196 (Achieva 1.5T); UDI-DI: N/A; Serial Numbers: 22135, 21807, 22149, 22162, 22186, 22264, 21329, 21787, 21989, 22022, 22150, 22180, 22270, 21674, 22080, 21190, 21254, 21315, 21530, 21592, 21903, 21913, 21914, 22072, 22076, 22161, 22176, 22217, 22278, 21796, 21996, 21306, 21499, 21525, 21556, 21626, 21897, 21985, 22213, 22056, 21342, 21571, 21594, 21810, 21924, 22335, 21235, 21492, 22198, 21243, 21449, 22029, 22069, 21731, 22095, 22185, 22239, 22108, 22079, 21984, 21073, 21211, 21269, 21487, 21488, 21550, 21598, 21624, 21808, 22071, 22223, 21911, 21225, 21954, 21215,Quantity: 387Recall no. Z-3232-2026Class II

  2. Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;

    Codes/lots: 1. Model Numbers (REF): 781177; UDI-DI: N/A; Serial Numbers: 17144, 17376, 17448, 24049, 17099, 24138, 24060, 17607, 17079, 17146, 17189, 17379, 17469, 17270, 17432, 17279, 17233, 17295, 17446, 17362, 24068, 24096, 17139, 24037, 24099, 17535, 24079, 17030, 17043, 17056, 17114, 17149, 17161, 17167, 17170, 17179, 17216, 17217, 17235, 17251, 17316, 17319, 17365, 17453, 17494, 17523, 17558, 17561, 24038, 24070, 24089; 2. Model Numbers (REF): 781277; UDI-DI: N/A; Serial Numbers: 34289, 34213, 34276, 34113, 34123, 34239, 34264, 34274, 34285, 34095, 34138, 34305, 34118, 34106, 34159, 34241, 34263, 34Quantity: 210Recall no. Z-3233-2026Class II

  3. Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;

    Codes/lots: 1. Model Numbers (REF): 781153; UDI-DI: N/A; Serial Numbers: 23035, 23003, 23021, 23028; 2. Model Numbers (REF): 781253; UDI-DI: N/A; Serial Numbers: 35028, 35068, 35083, 35074, 35049, 35004, 35006, 35011, 35015, 35050, 35076;Quantity: 15Recall no. Z-3234-2026Class II

  4. Evolution 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);

    Codes/lots: 1. Model Numbers (REF): 782116 (1.5T); UDI-DI: 884838099722; Serial Numbers: 41130, 70284, 41491, 41196, 41520, 70068, 41024, 41025, 41051, 41139, 41144, 41286, 41327, 41349, 41424, 41432, 41433, 70099, 70202, 81073, 41344, 41229, 41457, 41497, 41413, 41080, 41527, 70205, 70589, 81021, 41179, 41189, 70949; 2. Model Numbers (REF): 782148 (1.5T); UDI-DI: 884838108714; Serial Numbers: 41523, 70630, 70966, 84102, 84473, 84825, 41031, 41043, 41085, 41284, 41392, 41553, 70596, 81006, 70644, 41488, 41534, 70454, 41167, 41375, 41446, 70652, 41011, 70590, 70195, 84628; 3. Model Numbers (REF): 782117 (3Quantity: 91Recall no. Z-3235-2026Class II

  5. 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);

    Codes/lots: 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,Quantity: 2038Recall no. Z-3236-2026Class II

  6. 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);

    Codes/lots: 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, 48Quantity: 922Recall no. Z-3237-2026Class II

  7. Ingenia 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);

    Codes/lots: 1. Model Numbers (REF): 781342(3.0T); UDI-DI: 884838055339; Serial Numbers: 85106, 71152, 71526, 71812, 71179, 71252, 71328, 71342, 71419, 71550, 71551, 71555, 71557, 71674, 71693, 71949, 85036, 85155, 71266, 71345, 71392, 71395, 71628, 85393, 71216, 71651, 85208, 71163, 71408, 71499, 71541, 71668, 71771, 71602, 71260, 71276, 71324, 71726, 71068, 71300, 71482, 71339, 71452, 71464, 71465, 71468, 71470, 71471, 71472, 71473, 71479, 71480, 71492, 71497, 71506, 71509, 71511, 71514, 71516, 71517, 71519, 71520, 71548, 71553, 71554, 71559, 71560, 71567, 71588, 71596, 71601, 71605, 71609, 71614, 71621,Quantity: 1447Recall no. Z-3238-2026Class II

  8. Ingenia 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);

    Codes/lots: 1. Model Numbers (REF): 781357(S); UDI-DI: 884838088108; Serial Numbers: 46083, 46045, 46095, 46119, 46121, 46024, 46044, 46055, 46061, 46052, 46001, 46005, 46011, 46048, 46057, 46060, 46066, 46078, 46081, 46016, 46026, 46032, 46033, 46037, 46046, 46054, 46058, 46059, 46068, 46069, 46075, 46082, 46003, 46019, 46111, 46007, 46107, 46067, 46093, 46030, 46031, 46049, 46050, 46089, 46014, 46065, 46071, 46077, 46088, 46109; 2. Model Numbers (REF): 782106(S); UDI-DI: 884838098329; Serial Numbers: 46247, 46250, 46316, 46376, 46200, 46368, 46324, 46331, 46338, 46363, 46367, 46383, 46394, 46398, 46399,Quantity: 596Recall no. Z-3239-2026Class II

  9. Name (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-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);

    Codes/lots: 1. Intera 1.5T Model Numbers (REF): 781195; UDI-DI: N/A; Serial Numbers: 18774, 18781, 18951, 18958, 18962, 18971, 20431, 18898, 20429, 18669, 18981, 18982, 18734, 18763, 20427, 18842, 18654, 18878, 18566, 18618, 18752, 20409, 18748, 18743, 18657, 20424, 18755, 18908, 18501, 18646, 18768, 18516, 18554, 18616, 18723, 18725, 18784; 2. Intera 1.5T; Model Numbers (REF): 781295; UDI-DI: N/A; Serial Numbers: 30138, 30297, 30314, 30210, 30137, 30173, 30179, 30104, 30105, 30290, 30208, 30051, 30035, 30143, 30109, 30063, 30237, 30135; 3. Intera 1.5T Achieva IT Nova; Model Numbers (REF): (781175); UDI-DQuantity: 82Recall no. Z-3240-2026Class II

  10. MR 5300 Model Number (REF): 1. 782110, 2. 782152;

    Codes/lots: 1. Model Number (REF): 782110; UDI-DI: 884838099364; Serial Numbers: 63383, 63384, 63385, 63386, 63422, 63435, 63643, 63346, 63021, 63054, 63091, 63092, 63113, 63313, 63314, 63315, 63322, 63521, 63524, 63565, 63572, 63593, 63604, 63639, 63694, 63697, 63705, 63706, 63707, 63716, 63721, 63727, 63736, 63737, 63739, 63743, 63750, 63753, 63754, 63755, 63769, 63773, 63617, 63560, 63038, 63484, 63023, 63064, 63066, 63075, 63086, 63149, 63161, 63183, 63194, 63195, 63198, 63199, 63308, 63319, 63331, 63334, 63336, 63364, 63371, 63412, 63425, 63429, 63430, 63452, 63515, 63525, 63609, 63615, 63633, 63636,Quantity: 611Recall no. Z-3241-2026Class II

  11. MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);

    Codes/lots: 1. Model Number (REF): 782120; UDI-DI: 884838104112; Serial Numbers: 65002, 65003, 65014, 65015, 65050, 65029, 65056, 65018, 65021, 65035, 65038, 65000, 65025, 65006, 65008, 65043; 2. Model Number (REF): 782153; UDI-DI: 884838112858; Serial Numbers: 68011, 68022, 68031, 68014, 68012, 68009, 68033, 68053, 68023; 3. Model Number (REF): 782130; UDI-DI: 884838104402; Serial Numbers: 45007, 45052, 45043, 45044, 45552, 71616, 42164, 42066, 42104, 42248, 45263, 71532;Quantity: 37Recall no. Z-3242-2026Class II

  12. SmartPath 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 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);

    Codes/lots: 1. Model Number (System): 781260 (1.5T) UDI-DI: 884838095076; Serial Numbers: 32953, 8750, 8554, 9013, 18574, 18801, 18988, 20211, 32923, 32778, 8156, 8752, 10139, 10164, 21379, 21175, 32445, 11100, 18583, 18746, 18761, 18853, 18965, 18986, 20003, 21138, 21349, 21384, 21748, 22144, 22266, 30037, 30139, 30146, 32223, 32458, 33044, 33045, 33220, 33246, 33716, 72250, 5572, 8240, 8734, 8808, 8985, 10183, 12030, 20282, 21466, 32643, 8713, 8917, 10087, 10130, 18673, 18701, 18803, 32283, 22220, 8087, 8215, 8923, 13026, 22127, 32467, 8427, 10528, 8862, 21333, 21710, 21768, 22255, 22256, 22257, 21554, Quantity: 965Recall no. Z-3243-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

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