Ingenia 1.5T recall (Philips North America)

Medical deviceClass IIOngoing

Summary: Philips North America is recalling Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S); Software Versions: R11, R12 and R13;. Reason: 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.

What is being recalled

Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S); Software Versions: R11, R12 and R13;

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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. (states named: Georgia)

How to tell if yours is affected

1. Model number (REF): 1. 781315 (1.5T); UDI-DI: 00884838099715; Serial Numbers: 61005, 61007, 61014, 61033, 61036, 61047, 61056, 61057, 61076, 61087, 61088, 61105, 61116; 2. Model Number (REF): 781341 (1.5T); UDI-DI: 00884838055322; Serial Numbers: 70042, 70051, 70056, 70062, 70203, 70227, 70229, 70249, 70257, 70262, 70285, 70300, 70311, 70383, 70424, 70432, 70438, 70445, 70453, 70460, 70472, 70588, 70598, 70619, 70638, 70642, 70645, 70647, 70708, 70717, 70724, 70728, 70743, 70750, 70751, 70787, 70801, 70821, 70825, 70836, 70846, 70875, 70876, 70886, 70889, 70896, 70904, 70920, 70957, 70961, 70967, 70970, 70979, 70988, 84049, 84076, 84079, 84080, 84141, 84162, 84170, 84173, 84186, 84205, 84212, 84219, 84233, 84250, 84254, 84266, 84267, 84281, 84289, 84329, 84332, 84335, 84343, 84359, 84360, 84368, 84379, 84388, 84392, 84403, 84415, 84431, 84433, 84436, 84450, 84451, 84467, 84476, 84491, 84500, 84510, 84539, 84549, 84555, 84556, 84568, 84596, 84634, 84635, 84641, 84642, 84652, 84660, 84708, 84713, 84714, 84721, 84741, 84745, 84768, 84804, 84839, 84840, 84853, 84858, 84867, 84869, 84893, 84904, 84908, 84978, 84987, 87068, 87076, 87092, 87196, 87197, 87259; 3. Model Number (REF): 781396 (1.5T); UDI-DI: 00884838009820; Serial Numbers: 41000, 41001, 41021, 41034, 41046, 41056, 41061, 41091, 41116, 41145, 41194, 41231, 41249, 41253, 41254, 41255, 41352, 41354, 41356, 41370, 41400, 41408, 41422, 41428, 41456, 41475, 41492, 41513, 41515, 41548; 4. Model Number (REF): 782115 (1.5T); UDI-DI: 00884838099043; Serial Numbers: 61186, 61191, 61196, 61219, 61228, 61236, 61238, 61272, 61276, 61317, 61382, 61383, 61384, 61386, 61387, 61388, 61390, 61396, 61399, 61401, 61402, 61408, 61411, 61418, 61430; 5. Model Number (REF): 782140 (1.5T); UDI-DI: 00884838108646; Serial Numbers: 45608, 45609; 6. Model Number (REF): 781262 (1.5T CX); UDI-DI: 00884838068445; Serial Numbers: 77047, 77058, 77059, 77120, 77143, 77151, 77158, 77161, 77179, 77180, 77182; 7. Model Number (REF): 781347 (1.5T S); UDI-DI: 00884838068421; Serial Numbers: 81027, 81033, 81145;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Philips North America · all medical device recalls · recalls from August 2026

Official FDA record