Home / Recalls / Philips North America / Z-3313-2026

Z-3313-2026 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

FDA device recall Z-3313-2026 was initiated by Philips North America on Aug 28, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 107.

Recall Details

Product Type: Devices
Report Date: Oct 7, 2026
Initiation Date: Aug 28, 2026
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 107

Product Description

MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;

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.

Distribution Pattern

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.

Code Information

1. Model number (REF): 782120; UDI-DI: 00884838104112; Serial Numbers: 65000, 65001, 65002, 65003, 65004, 65005, 65006, 65008, 65009, 65011, 65012, 65013, 65014, 65015, 65016, 65017, 65018, 65019, 65020, 65021, 65023, 65024, 65025, 65026, 65027, 65028, 65029, 65030, 65031, 65032, 65034, 65035, 65038, 65039, 65040, 65041, 65042, 65043, 65049, 65050, 65051, 65056, 65059, 65060, 65061, 65063, 65064, 65065, 65066, 65067; 2. Model Number (REF): 782153; UDI-DI: 00884838112858; Serial Numbers: 68000, 68001, 68006, 68007, 68008, 68009, 68010, 68013, 68014, 68016, 68017, 68018, 68019, 68020, 68021, 68022, 68023, 68024, 68025, 68026, 68028, 68029, 68030, 68031, 68032, 68033, 68034, 68036, 68037, 68041, 68042, 68043, 68047, 68049, 68050; 3. Model Number (REF): 782155; UDI-DI: 00884838115668; Serial Numbers: 94000, 94002, 94004, 94006, 94007, 94008, 94009, 94011, 94012, 94013, 94014, 94015, 94016, 94021, 94023, 94024; 4. Model Number (REF): 782199; UDI-DI: 00884838128439; Serial Numbers: 19300, 19303, 19304, 19309, 19312, 19313;

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-3313-2026
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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