Class II U.S. Food and Drug Administration

Philips North America Ingenia Ambition S and Ingenia Ambition X recall: When exporting diffusion tensor imaging (DTI) scans from a MR system using

Recall published 18 days ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3310-2026
Published
October 7, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Philips North America
Product type
Medical devices
Units affected
422
Distribution
Nationwide
Made in
United States
Lot / code info
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;
UPC codes
00884838090057, 00884838098343, 00884838108639, 00884838115705, 00884838128477, 00884838090040, 00884838098350, 00884838108622, 00884838115712, 00884838128484

Products covered by this recall

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;

Check your product

The notice names 30 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00884838090057
  • 00884838098343
  • 00884838108639
  • 00884838115705
  • 00884838128477
  • 00884838090040
  • 00884838098350
  • 00884838108622
  • 00884838115712
  • 00884838128484

Serial number

On the rating plate, often next to the date of manufacture.

  • 48010
  • 48023
  • 48028
  • 48047
  • 48122
  • 48160
  • 48507
  • 48510
  • 48530
  • 48548
  • 48554
  • 48576
  • 29016
  • 29017
  • 29018
  • 29020
  • 29026
  • 29029
  • 91007
  • 91027

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Philips North America — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Philips North America — 222 Jacobs St, Cambridge, MA, 02141-2296

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Philips North America medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884838090057, 00884838098343, 00884838108639. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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