The Recall Desk

Manufacturer

Philips North America

140 recalls in our database name Philips North America as the manufacturing or recalling firm.

What the numbers show

Total
140
Critical
0
Severe
11
Most recent
2026-10-07

Of the 140 recalls from Philips North America we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 140

  • ModerateFDA (Devices)·Z-3307-2026·2026-10-07

    Philips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors

    Philips is recalling six Ingenia Blue Seal MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate tractography reconstruction.

    Product
    Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3310-2026·2026-10-07

    Philips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports

    Philips is recalling Ingenia Ambition S and X MRI systems because diffusion tensor imaging (DTI) exports contain incorrect data, preventing correct processing by third-party software.

    Product
    Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3316-2026·2026-10-07

    Philips Upgrade dStream Software Recall for Incorrect DTI Data Exports

    Philips is recalling Upgrade dStream software versions R11-R13 because DTI scan exports contain incorrect diffusion direction data, preventing correct tractography reconstruction.

    Product
    Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3315-2026·2026-10-07

    Philips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data

    Philips is recalling five SmartPath to MR 7700 units because diffusion tensor imaging exports contain incorrect data, preventing correct processing by third-party software.

    Product
    SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3312-2026·2026-10-07

    Philips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data

    Philips North America is recalling 131 MR 5300 systems because diffusion tensor imaging exports contain incorrect data, preventing accurate tractography reconstruction.

    Product
    MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3314-2026·2026-10-07

    Philips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data

    Philips is recalling SmartPath MRI software because it exports incorrect diffusion tensor imaging data, preventing correct processing by third-party tractography software.

    Product
    SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782165 (1.5T), 5. 782145 (3.0T), 6. 782164 (3.0T), 7. 781270 (XR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3311-2026·2026-10-07

    Philips Recalls Ingenia MRI Systems Due to Incorrect DTI Export Data

    Philips is recalling 340 Ingenia MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate third-party processing.

    Product
    Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. 782198 (X); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3308-2026·2026-10-07

    Philips Ingenia MRI Systems Recalled for Incorrect DTI Export Data

    Philips is recalling Ingenia 1.5T MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate processing by third-party software.

    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;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3318-2026·2026-10-07

    Philips MRI Systems Recalled for Incorrect Diffusion Tensor Imaging Data Exports

    Philips is recalling 91 Evolution MRI systems because Enhanced MR DICOM exports contain incorrect diffusion directions, preventing correct tractography reconstruction.

    Product
    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;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3309-2026·2026-10-07

    Philips Ingenia MRI Systems Recalled for Incorrect DTI Data Exports

    Philips is recalling Ingenia 3.0T MRI systems because diffusion tensor imaging exports contain incorrect data, preventing accurate tractography reconstruction.

    Product
    Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3313-2026·2026-10-07

    Philips MR 7700 MRI Systems Recalled for Incorrect DTI Data Exports

    Philips is recalling 107 MR 7700 MRI systems because diffusion tensor imaging (DTI) exports contain incorrect data, preventing accurate tractography reconstruction.

    Product
    MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3317-2026·2026-10-07

    Philips MR 7700 Software Upgrade Recalled for Incorrect DTI Data

    Philips is recalling 30 MR 7700 software upgrades because they export incorrect diffusion tensor imaging data, preventing accurate nerve fiber mapping.

    Product
    Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3142-2026·2026-09-23

    Philips PIC iX Essentials Patient Information System Software Recall

    Philips North America is recalling 312 units of the PIC iX Essentials patient information system due to a software malfunction that may cause the system to freeze.

    Product
    Philips PIC iX Essentials REF:867093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3141-2026·2026-09-23

    Philips Patient Information Center iX Software Malfunction Recall

    Philips North America is recalling 7,359 Patient Information Center iX units due to a software malfunction that may cause the system to freeze and become unresponsive.

    Product
    Philips Patient Information Center iX REF:866389
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2026·2026-05-06

    Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall

    Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.

    Product
    Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2026·2026-05-06

    Philips Evolution Upgrade 1.5T MRI Stiffness Calculation Error

    Philips North America is recalling Philips Evolution Upgrade 1.5T MRI systems with MR Elastography due to potential stiffness value errors that may result in incorrect voxel size settings in the default scan protocol.

    Product
    Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1960-2026·2026-05-06

    Philips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors

    Philips is recalling certain Ingenia Ambition S MRI systems with MR Elastography software due to potential stiffness value errors that may occur when specific image reconstruction parameters are used in combination with Resoundant's algorithm.

    Product
    Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2026·2026-05-06

    Philips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk

    Philips is recalling 15 units of its MR 7700 with MR Elastography upgrade due to potential stiffness value errors in MRI scans when specific image reconstruction parameters are used with the Resoundant algorithm.

    Product
    Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1953-2026·2026-05-06

    Philips Achieva 3.0T MR Elastography system stiffness value error recall

    Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.

    Product
    Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1965-2026·2026-05-06

    Philips SmartPath to dStream MR Elastography System Reconstruction Error

    Philips is recalling certain SmartPath to dStream 1.5T MR Elastography systems due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause incorrect voxel size settings in the default MRE scan protocol.

    Product
    Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1962-2026·2026-05-06

    Philips Ingenia Elition S MRI stiffness value error correction

    Philips Ingenia Elition S MRI systems with MR Elastography may display incorrect voxel size settings in the default scan protocol when certain image reconstruction parameters are used, potentially leading to stiffness value errors.

    Product
    Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1963-2026·2026-05-06

    Philips Ingenia Elition X MRI Scanner Recall for Image Reconstruction Error

    Philips is recalling Ingenia Elition X MRI scanners with MR Elastography due to potential errors in stiffness value measurements when specific image reconstruction parameters are used, which may cause incorrect voxel size display in the default scan protocol.

    Product
    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1961-2026·2026-05-06

    Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall

    Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.

    Product
    Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2026·2026-05-06

    Philips SmartPath to dStream MR Elastography Software Parameter Error

    Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.

    Product
    Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2026·2026-05-06

    Philips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors

    Philips is recalling three models of SmartPath to Ingenia Elition X with MR Elastography devices due to potential stiffness value errors when specific image reconstruction parameters are combined with Resoundant's algorithm.

    Product
    Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
    Category
    Medical Device
    Distribution
    Distributed nationwide