The Recall Desk

Manufacturer

Philips North America, LLC

423 recalls in our database name Philips North America, LLC as the manufacturing or recalling firm.

What the numbers show

Total
423
Critical
2
Severe
27
Most recent
2026-10-07

Of the 423 recalls from Philips North America, LLC we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (6%) 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 423

  • HighFDA (Devices)·Z-3155-2026·2026-10-07

    Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk

    Philips is recalling Spectral CT 7500 software due to a tracking crash that may cause patients to receive additional radiation.

    Product
    Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3232-2026·2026-09-30

    Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue

    Philips is recalling 387 Achieva 1.5T MRI systems worldwide because a software issue may terminate examinations if manual scan adjustments exceed system memory.

    Product
    Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3241-2026·2026-09-30

    Philips MR 5300 MRI Scanner Software Recall for Image Reconstruction Failure

    Philips is recalling 611 MR 5300 MRI scanners due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.

    Product
    MR 5300 Model Number (REF): 1. 782110, 2. 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3238-2026·2026-09-30

    Philips Ingenia MRI Software Recall for Memory-Related Scan Termination

    Philips is recalling Ingenia 3.0T and 3.0T CX MRI systems because a software issue can terminate examinations during image reconstruction if scan parameters exceed available system memory.

    Product
    Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3235-2026·2026-09-30

    Philips MRI Software Recall for Image Reconstruction Failure

    Philips is recalling 91 MRI systems due to a software issue that can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.

    Product
    Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3237-2026·2026-09-30

    Philips Ingenia Ambition MRI Software Recall for Memory Limit Issue

    Philips is recalling 922 Ingenia Ambition MRI systems due to a software issue that can terminate examinations if system memory is exceeded.

    Product
    Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3242-2026·2026-09-30

    Philips MR 7700 MRI Systems Recalled for Software Issue

    Philips is recalling 37 MR 7700 MRI systems due to a software issue that can terminate examinations during image reconstruction.

    Product
    MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3233-2026·2026-09-30

    Philips Achieva 3.0T MRI Software Recall for Memory Limit Issues

    Philips is recalling 210 Achieva 3.0T MRI scanners because a software issue can terminate examinations if system memory is exceeded during image reconstruction.

    Product
    Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3240-2026·2026-09-30

    Philips Intera 1.5T MRI Systems Recalled for Software Issue

    Philips is recalling 82 Intera 1.5T MRI systems worldwide because a software issue can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.

    Product
    Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3236-2026·2026-09-30

    Philips Ingenia MRI Software Recall for Image Reconstruction Failure

    Philips is recalling 2,038 Ingenia 1.5T MRI systems worldwide due to a software issue that can terminate examinations during image reconstruction if specific scan parameters are manually adjusted.

    Product
    Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3243-2026·2026-09-30

    Philips MRI Software Recall for Image Reconstruction Failure

    Philips is recalling SmartPath MRI software due to a defect that can terminate examinations during image reconstruction if system memory is exceeded.

    Product
    SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3234-2026·2026-09-30

    Philips Achieva XR MRI Systems Recalled for Software Memory Issue

    Philips is recalling 15 Achieva XR MRI systems because a software issue can terminate examinations if scan parameters exceed system memory.

    Product
    Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3239-2026·2026-09-30

    Philips Ingenia MRI Software Recall for Image Reconstruction Failure

    Philips is recalling 596 Ingenia Elition MRI systems due to a software issue that can terminate examinations during image reconstruction if system memory is exceeded.

    Product
    Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3040-2026·2026-09-09

    Philips Brilliance CT Systems Recalled for Unintended Radiation Issue

    Philips is recalling Brilliance CT systems due to an unintended radiation issue that could affect equipment performance.

    Product
    Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3043-2026·2026-09-09

    Philips CT Systems Recalled for Unintended Radiation Performance Issues

    Philips is recalling Brilliance CT 64 systems due to an unintended radiation issue that could affect equipment performance.

    Product
    Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3041-2026·2026-09-09

    Philips Recalls IQon Spectral CT Systems Due to Radiation Issue

    Philips is recalling IQon Spectral CT systems due to an unintended radiation issue that could affect equipment performance.

    Product
    Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3042-2026·2026-09-09

    Philips CT Systems Recalled for Unintended Radiation Performance Issues

    Philips is recalling specific CT systems due to an unintended radiation issue that could affect equipment performance.

    Product
    Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2523-2026·2026-07-01

    Philips Avalon Fetal Monitor FM 30 Speaker Connector Assembly

    Philips is recalling 169 units of the Avalon Fetal Monitor FM 30 due to incorrect speaker connector assembly that can cause device cables to disconnect, resulting in loss of speaker output.

    Product
    Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2579-2026·2026-07-01

    Philips Telemetry Monitor 5500 Device Reset Risk Recall

    Philips Telemetry Monitor 5500 (Model 867232) may unexpectedly reset to default "NEW_DEVICE" state, causing loss of device configuration and disconnection from the PIC iX central monitoring system.

    Product
    Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2522-2026·2026-07-01

    Philips Avalon Fetal Monitor FM20 Speaker Connector Assembly Recall

    Philips is recalling certain Avalon Fetal Monitor FM20 units worldwide due to incorrect speaker connector assembly that can cause device cables to be pulled out, leading to loss of speaker output.

    Product
    Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2354-2026·2026-06-17

    Philips DigitalDiagnost C90 delivered without required wall stand seismic kit

    A DigitalDiagnost C90 radiography system is being recalled because it was delivered without the seismic kit required for the Wall Stand VS2. One unit is affected.

    Product
    DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1316-2026·2026-02-18

    IQon Spectral CT recalled over rotor fasteners that may be undertorqued

    Philips is recalling 52 IQon Spectral CT units because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.

    Product
    IQon Spectral CT; Product Code (REF): 728332;
    Category
    Medical Device
    Distribution
    Distributed nationwide