FDA Class II · Medical device · Recall Z-3310-2026 · Recalled October 7, 2026
Ingenia Ambition S and Ingenia Ambition X recall — Philips North America Compare identifiers Agency action Open official record ↗ Agency report date: October 7, 2026.
Source checks: October 22, 2026 at 12:00 PM UTC (oldest successful check).
Sources, dates and coverage limits We collect recent notices on a six-hour schedule using a rolling 90-day source request. Older retained records may also appear. This is a recall index, not a catalogue of all products or a complete recall history.
FDA: stored recall dates April 29, 2026 to October 14, 2026. USDA FSIS is not aggregated here. Check USDA meat, poultry and processed egg notices . EPA and U.S. Coast Guard are not aggregated. Source delays and missing identifiers can prevent a match.
1. Compare your item This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named Ingenia Ambition S and Ingenia Ambition X Company / brand Philips North America Lot / serial / date codes 1. Model number (REF): 781359 (S); UDI-DI: 00884838090057; Serial Numbers: 48010, 48023, 48028, 48047, 48122, 48160, 48173, 48180, 48196, 48286; 2. Model Number (REF): 782108 (S); UDI-DI: 00884838098343; Serial Numbers: 48507, 48510, 48530, 48548, 48554, 48576, 48577, 48580, 48586, 48607, 48616, 48620, 48653, 48686, 48688, 48726, 48746, 48778, 48818, 48831, 48847, 48872, 48878, 48888, 48893, 48896, 48897, 48917, 48922, 48931; 3. Model Number (REF): 782139 (S); UDI-DI: 00884838108639; Serial Numbers: 29016, 29017, 29018, 29020, 29026, 29029, 29031, 29041, 29054, 29063, 29069, 29071, 29076, 29078, 29079, 29086, 29104, 29115, 29118, 29144, 29145, 29150, 29160, 29164, 29169; 4. Model Number (REF): 782159 (S); UDI-DI: 00884838115705; Serial Numbers: 91007, 91027, 91031, 91038, 91043, 91051; 5. Model Number (REF): 782194 (S); UDI-DI: 00884838128477; Serial Numbers: 22401, 22410; 6. Model Number (REF): 781356 (X); UDI-DI: 00884838090040; Serial Numbers: 47004, 47006, 47011, 47012, 47013, 47014, 47018, 47020, 47026, 47027, 47028, 47029, 47037, 47038, 47039, 47043, 47048, 47051, 47057, 47059, 47063, 47067, 47068, 47070, 47092, 47094, 47098, 47099, 47177, 47187, 47188, 47189, 47195, 47197, 47199, 47203, 47206, 47211, 47215, 47221, 47222, 47233, 47237, 47242, 47248, 47253, 47260, 47268, 47270, 47271, 47274, 47276, 47278, 47279, 47281, 47282, 47289, 47290, 47292, 47294, 47297, 47303, 47305, 47313, 47314, 47322, 47344, 47347, 47348, 47351, 47353, 47356, 47371; 7. Model Number (REF): 782109 (X); UDI-DI: 00884838098350; Serial Numbers: 47502, 47503, 47505, 47507, 47508, 47512, 47517, 47518, 47519, 47520, 47534, 47535, 47541, 47542, 47543, 47549, 47552, 47555, 47558, 47562, 47567, 47568, 47569, 47570, 47572, 47580, 47588, 47589, 47590, 47594, 47595, 47596, 47598, 47599, 47608, 47610, 47612, 47614, 47615, 47622, 47623, 47634, 47642, 47646, 47648, 47651, 47653, 47654, 47661, 47662, 47663, 47668, 47669, 47671, 47674, 47681, 47682, 47687, 47692, 47693, 47694, 47699, 47700, 47702, 47703, 47706, 47709, 47710, 47711, 47714, 47717, 47718, 47719, 47721, 47722, 47723, 47724, 47726, 47727, 47728, 47729, 47730, 47731, 47732, 47733, 47752, 47760, 47761, 47762, 47766, 47767, 47771, 47778, 47779, 47780, 47781, 47788, 47789, 47795, 47796, 47797, 47800, 47807, 47808, 47809, 47812, 47815, 47816, 47817, 47818, 47820, 47823, 47824, 47826, 47834, 47839, 47843, 47848, 47849, 47851, 47862, 47863, 47864, 47874, 47876, 47881, 47882, 47884, 47885, 47886, 47887, 47891, 47892, 47893, 47894, 47895, 47899, 47932, 47944, 47962; 8. Model Number (REF): 782138 (X); UDI-DI: 00884838108622; Serial Numbers: 49000, 49001, 49004, 49014, 49015, 49019, 49020, 49022, 49025, 49027, 49028, 49033, 49037, 49038, 49041, 49043, 49045, 49047, 49048, 49049, 49053, 49056, 49057, 49058, 49062, 49063, 49071, 49072, 49075, 49097, 49099, 49100, 49102, 49106, 49109, 49111, 49113, 49124, 49128, 49129, 49136, 49145, 49153, 49154, 49155, 49156, 49158, 49161, 49162, 49163, 49164, 49165, 49168, 49170, 49171, 49172, 49174, 49177, 49178, 49180, 49183, 49189, 49190, 49194, 49196, 49197, 49203, 49206, 49207, 49210, 49212, 49215, 49216, 49217, 49219, 49220, 49221, 49222, 49223, 49228, 49229, 49230, 49231, 49233, 49237, 49238, 49243, 49246, 49247, 49250, 49251, 49253, 49257, 49261, 49265, 49268, 49269, 49270, 49272, 49282, 49287, 49288, 49290, 49291; 9. Model Number (REF): 782160 (X); UDI-DI: 00884838115712; Serial Numbers: 92000, 92003, 92006, 92016, 92022, 92024, 92028, 92029, 92031, 92035, 92036, 92039, 92042, 92046, 92053, 92056, 92067, 92068, 92069, 92070, 92072, 92084, 92097; 10. Model Number (REF): 782195 (X); UDI-DI: 00884838128484; Serial Numbers: 55004, 55005, 55011, 55012, 55018, 55019, 55021, 55024, 55032; Distribution Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam. Agency product description and boundaries Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action FDA reports: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: Ingenia Ambition S and Ingenia Ambition X recall status
3. Open the official notice or contact View the official FDA enforcement record (openFDA) ↗
Official recall ID Z-3310-2026 Brand All Philips North America recalls Classification Class II Units affected 422 Recall status Ongoing Initiated Voluntary: Firm initiated Affected products Companies & origin Recalling firm location Cambridge, MA, United States Firm address 222 Jacobs St, 02141-2296 Identifying details (verbatim from the notice) Product codes / lots 1. Model number (REF): 781359 (S); UDI-DI: 00884838090057; Serial Numbers: 48010, 48023, 48028, 48047, 48122, 48160, 48173, 48180, 48196, 48286; 2. Model Number (REF): 782108 (S); UDI-DI: 00884838098343; Serial Numbers: 48507, 48510, 48530, 48548, 48554, 48576, 48577, 48580, 48586, 48607, 48616, 48620, 48653, 48686, 48688, 48726, 48746, 48778, 48818, 48831, 48847, 48872, 48878, 48888, 48893, 48896, 48897, 48917, 48922, 48931; 3. Model Number (REF): 782139 (S); UDI-DI: 00884838108639; Serial Numbers: 29016, 29017, 29018, 29020, 29026, 29029, 29031, 29041, 29054, 29063, 29069, 29071, 29076, 29078, 29079, 29086, 29104, 29115, 29118, 29144, 29145, 29150, 29160, 29164, 29169; 4. Model Number (REF): 782159 (S); UDI-DI: 00884838115705; Serial Numbers: 91007, 91027, 91031, 91038, 91043, 91051; 5. Model Number (REF): 782194 (S); UDI-DI: 00884838128477; Serial Numbers: 22401, 22410; 6. Model Number (REF): 781356 (X); UDI-DI: 00884838090040; Serial Numbers: 47004, 47006, 47011, 47012, 47013, 47014, 47018, 47020, 47026, 47027, 47028, 47029, 47037, 47038, 47039, 47043, 47048, 47051, 47057, 47059, 47063, 47067, 47068, 47070, 47092, 47094, 47098, 47099, 47177, 47187, 47188, 47189, 47195, 47197, 47199, 47203, 47206, 47211, 47215, 47221, 47222, 47233, 47237, 47242, 47248, 47253, 47260, 47268, 47270, 47271, 47274, 47276, 47278, 47279, 47281, 47282, 47289, 47290, 47292, 47294, 47297, 47303, 47305, 47313, 47314, 47322, 47344, 47347, 47348, 47351, 47353, 47356, 47371; 7. Model Number (REF): 782109 (X); UDI-DI: 00884838098350; Serial Numbers: 47502, 47503, 47505, 47507, 47508, 47512, 47517, 47518, 47519, 47520, 47534, 47535, 47541, 47542, 47543, 47549, 47552, 47555, 47558, 47562, 47567, 47568, 47569, 47570, 47572, 47580, 47588, 47589, 47590, 47594, 47595, 47596, 47598, 47599, 47608, 47610, 47612, 47614, 47615, 47622, 47623, 47634, 47642, 47646, 47648, 47651, 47653, 47654, 47661, 47662, 47663, 47668, 47669, 47671, 47674, 47681, 47682, 47687, 47692, 47693, 47694, 47699, 47700, 47702, 47703, 47706, 47709, 47710, 47711, 47714, 47717, 47718, 47719, 47721, 47722, 47723, 47724, 47726, 47727, 47728, 47729, 47730, 47731, 47732, 47733, 47752, 47760, 47761, 47762, 47766, 47767, 47771, 47778, 47779, 47780, 47781, 47788, 47789, 47795, 47796, 47797, 47800, 47807, 47808, 47809, 47812, 47815, 47816, 47817, 47818, 47820, 47823, 47824, 47826, 47834, 47839, 47843, 47848, 47849, 47851, 47862, 47863, 47864, 47874, 47876, 47881, 47882, 47884, 47885, 47886, 47887, 47891, 47892, 47893, 47894, 47895, 47899, 47932, 47944, 47962; 8. Model Number (REF): 782138 (X); UDI-DI: 00884838108622; Serial Numbers: 49000, 49001, 49004, 49014, 49015, 49019, 49020, 49022, 49025, 49027, 49028, 49033, 49037, 49038, 49041, 49043, 49045, 49047, 49048, 49049, 49053, 49056, 49057, 49058, 49062, 49063, 49071, 49072, 49075, 49097, 49099, 49100, 49102, 49106, 49109, 49111, 49113, 49124, 49128, 49129, 49136, 49145, 49153, 49154, 49155, 49156, 49158, 49161, 49162, 49163, 49164, 49165, 49168, 49170, 49171, 49172, 49174, 49177, 49178, 49180, 49183, 49189, 49190, 49194, 49196, 49197, 49203, 49206, 49207, 49210, 49212, 49215, 49216, 49217, 49219, 49220, 49221, 49222, 49223, 49228, 49229, 49230, 49231, 49233, 49237, 49238, 49243, 49246, 49247, 49250, 49251, 49253, 49257, 49261, 49265, 49268, 49269, 49270, 49272, 49282, 49287, 49288, 49290, 49291; 9. Model Number (REF): 782160 (X); UDI-DI: 00884838115712; Serial Numbers: 92000, 92003, 92006, 92016, 92022, 92024, 92028, 92029, 92031, 92035, 92036, 92039, 92042, 92046, 92053, 92056, 92067, 92068, 92069, 92070, 92072, 92084, 92097; 10. Model Number (REF): 782195 (X); UDI-DI: 00884838128484; Serial Numbers: 55004, 55005, 55011, 55012, 55018, 55019, 55021, 55024, 55032; Distribution Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, T¿rkiye, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam. Firm notified the public via Letter FDA event ID 99834 Recall initiated August 28, 2026 FDA classified September 25, 2026 FDA report date October 7, 2026 Other medical device recalls from around the same time
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes;
the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.
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