Fresh Recalls

MR 5300: recall status

Notice names this product. Philips North America’s MR 5300 is named in FDA Class II recall Z-3312-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: 1. Model number (REF): 782110; UDI-DI: 00884838099364; Serial Numbers: 63007, 63027, 63064, 63076, 63097, 63123, 63132, 63137, 63148, 63150, 63160, 63236, 63237, 63238, 63258, 63300, 63302, 63360, 63370, 63394, 63397, 63398, 63445, 63523, 63576, 63599, 63636, 63696, 63735, 63766, 63767, 63774, 63806; 2. Model Number (REF): 782152; UDI-DI: 00884838112841; Serial Numbers: 69000, 69007, 69008, 69012, 69015, 69016, 69017, 69030, 69048, 69067, 69068, 69070, 69071, 69076, 69078, 69089, 69094, 69096, 69097, 69101, 69102, 69110, 69121, 69124, 69126, 69128, 69134, 69135, 69137, 69143, 69150, 69154, 69160, 69161, 69171, 69175, 69180, 69193, 69194, 69198, 69209, 69212, 69238, 69239, 69240, 69241, 69247, 69249, 69250, 69263, 69264, 69265, 69266, 69287, 69289, 69290, 69299, 69300, 69304, 69307, 69309, 69310, 69312, 69316, 69318, 69319, 69320, 69321, 69338, 69342, 69344, 69345, 69366, 69367; 3. Model Number (REF): 782156; UDI-DI: 00884838115675; Serial Numbers: 93000, 93007, 93008, 93018, 93023, 93026, 93028, 93037, 93054, 93073, 93084, 93100, 93101, 93102, 93103, 93104, 93105, 93106; 4. Model Number (REF): 782196; UDI-DI: 00884838128446; Serial Numbers: 54016, 54024, 54036, 54040, 54050, 54054;. Units affected: 131. Status: Ongoing.

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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
MR 5300
Company / brand
Philips North America
Lot / serial / date codes
1. Model number (REF): 782110; UDI-DI: 00884838099364; Serial Numbers: 63007, 63027, 63064, 63076, 63097, 63123, 63132, 63137, 63148, 63150, 63160, 63236, 63237, 63238, 63258, 63300, 63302, 63360, 63370, 63394, 63397, 63398, 63445, 63523, 63576, 63599, 63636, 63696, 63735, 63766, 63767, 63774, 63806; 2. Model Number (REF): 782152; UDI-DI: 00884838112841; Serial Numbers: 69000, 69007, 69008, 69012, 69015, 69016, 69017, 69030, 69048, 69067, 69068, 69070, 69071, 69076, 69078, 69089, 69094, 69096, 69097, 69101, 69102, 69110, 69121, 69124, 69126, 69128, 69134, 69135, 69137, 69143, 69150, 69154, 69160, 69161, 69171, 69175, 69180, 69193, 69194, 69198, 69209, 69212, 69238, 69239, 69240, 69241, 69247, 69249, 69250, 69263, 69264, 69265, 69266, 69287, 69289, 69290, 69299, 69300, 69304, 69307, 69309, 69310, 69312, 69316, 69318, 69319, 69320, 69321, 69338, 69342, 69344, 69345, 69366, 69367; 3. Model Number (REF): 782156; UDI-DI: 00884838115675; Serial Numbers: 93000, 93007, 93008, 93018, 93023, 93026, 93028, 93037, 93054, 93073, 93084, 93100, 93101, 93102, 93103, 93104, 93105, 93106; 4. Model Number (REF): 782196; UDI-DI: 00884838128446; Serial Numbers: 54016, 54024, 54036, 54040, 54050, 54054;
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

MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;

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Brand
Philips North America

Recalls naming this model

FDA Class II · Medical device · October 7, 2026

MR 5300 recall — Philips North America

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 …

Company / brand: Philips North America recalls

Affected product: MR 5300 recall status

Official ID Z-3312-2026 · Official record ↗

See all Philips North America recalls →

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.