Z-3308-2026

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)...

Name: Z-3308-2026 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)...
Creator: Philips North America
Published: 2026-08-28
License: https://open.fda.gov/license/

Philips North America / initiated 2026-08-28 / Open, Classified

FDA source

Recall record

Recall number: Z-3308-2026
Status: Open, Classified
Initiated: 2026-08-28
Posted: 2026-09-25
Recalling firm: Philips North America
Product: 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;
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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.
FDA root cause: Software design
Action: On August 28, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. To prevent the issue from occurring while Philips is developing the software solution, use the Classic DICOM transfer option for exporting DTI scans. 2. You may continue to use your system(s) in accordance with the intended use. 3. Circulate this notice to all users of this device so that they are aware of the issue and associated hazard/harm. 4. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed.
Quantity in commerce: 216
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.
Product codes and lots: 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;

Product code LNH

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)