FDA Medical Device · Z-3318-2026

Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T); Software Versions: R11, R12 and R13;

Class II · Ongoing

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.

Affected lots / codes — check yours against this1. Model number (REF): 782116 (1.5T); UDI-DI: 00884838099722; Serial Numbers: 41042, 41235, 41287, 41295, 41367, 41505, 41568, 70068, 70093, 70995, 70996, 84370; 2. Model number (REF): 782148 (1.5T); UDI-DI: 00884838108714; Serial Numbers: 41011, 41031, 41110, 41244, 41277, 41334, 41427, 41446, 41464, 41523, 41534, 70425, 70454, 70473, 70622, 70630, 70644, 70769, 70803, 70966, 70983, 84102, 84409, 84560, 84569, 84630, 84825; 3. Model number (REF): 782166 (1.5T); UDI-DI: 00884838115774; Serial Numbers: 41005, 41161, 41485, 41499, 41572, 70155, 70206, 70826, 84048, 84270, 84541; 4. Model number (REF): 782201 (1.5T); UDI-DI: 00884838128552; Serial Numbers: 84018, 84648; 5. Model number (REF): 782117 (3.0T); UDI-DI: 00884838099739; Serial Numbers: 42023, 42024, 42078, 42375, 71348, 85681, 85705; 6. Model number (REF): 782143 (3.0T); UDI-DI: 00884838108660; Serial Numbers: 42069, 42225, 42254, 42318, 42366, 42415, 42440, 71389, 71460, 71595, 71815, 71836, 85649, 85651, 85654, 85682, 85683, 85688, 85690, 85695, 85697, 85699, 85701, 85714; 7. Model number (REF): 782162 (3.0T); UDI-DI: 00884838115736; Serial Numbers: 42184, 42369, 71074, 71403, 71433, 71574, 71740, 85145;

Recalling firm: Philips North America, Cambridge, MA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 91
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, Gre…
Recall initiated: August 28, 2026
Classified: September 25, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3318-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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