The Recall Desk

Manufacturer

Philips North America, LLC

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

What the numbers show

Total
410
Critical
2
Severe
26
Most recent
2026-09-09

Of the 410 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 26 (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.

201–225 of 410

  • HighFDA (Devices)·Z-0576-2024·2023-12-27

    Philips Inclusive CT Systems: Software Errors in Image Display and Interpretation

    Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.

    Product
    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment suppor
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-0505-2024·2023-12-20

    Philips Panorama MR System Structural Failure Risk from Helium Gas Pressure

    Philips Panorama 1.0T MR Systems (Models 781250, 781350) may experience structural failure during helium quench events, releasing pressurized gas and debris that could cause helium exposure, asphyxia, and injury to patients and operators.

    Product
    Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0389-2024·2023-11-29

    Philips Achieva 1.5T MRI systems recalled for potential gradient coil fire risk

    Philips is recalling Achieva 1.5T MRI systems due to potential gradient coil failure that could produce smoke and/or fire. Approximately 520 units have been distributed nationwide and internationally.

    Product
    Achieva 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2024·2023-11-29

    Philips Achieva 1.5T MRI Device Recalled for Gradient Coil Fire Risk

    Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.

    Product
    Achieva 1.5T Conversion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2024·2023-11-29

    Philips MRI systems recalled for potential gradient coil fire hazard

    Philips is recalling 102 Intera 1.5T MRI systems worldwide due to a potential gradient coil failure that could produce smoke and fire. The affected devices are identified by product numbers 781195 and 781295.

    Product
    Intera 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0391-2024·2023-11-29

    Philips Achieva 1.5T MRI Systems Recalled for Gradient Coil Fire Risk

    Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units distributed worldwide.

    Product
    Achieva 1.5T Initial System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0394-2024·2023-11-29

    Intera 1.5T MRI System Recall: Gradient Coil Fire Risk

    Philips is recalling the Intera 1.5T Power/Pulsar MRI system due to potential failure in the gradient coil component that could produce smoke and/or fire.

    Product
    Intera 1.5T Power/Pulsar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2024·2023-11-29

    Philips MRI Gradient Coil Recall Due to Fire and Smoke Risk

    Philips is recalling SmartPath to dStream 1.5T MRI systems due to a potential gradient coil failure that could produce smoke or fire. The recall affects 119 units distributed nationwide and internationally.

    Product
    SmartPath to dStream for 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0392-2024·2023-11-29

    MRI Machine Gradient Coil Potential Failure Could Produce Smoke and Fire

    Philips Ingenia 1.5T CX MRI systems may experience gradient coil failure that could produce smoke and/or fire. The FDA has classified this as a Class II recall affecting 48 units distributed nationwide and internationally.

    Product
    Ingenia 1.5T CX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2024·2023-11-22

    Philips Big Bore RT CT Scanner Defect May Cause Incorrect Treatment Planning

    A software defect in Philips Big Bore RT CT scanners may cause incorrect coordinates in radiation therapy planning systems, affecting 56 units distributed nationwide and internationally.

    Product
    Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0294-2024·2023-11-22

    CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning

    A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.

    Product
    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2024·2023-11-22

    Philips Brilliance CT Big Bore May Send Incorrect Coordinates During Radiation Therapy Planning

    Philips Brilliance CT Big Bore units with software V4.8.0.10421 may produce inaccurate image position data when offset reconstruction is used. This could lead to incorrect radiation therapy planning or diagnosis.

    Product
    Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2024·2023-11-15

    Philips DigitalDiagnost C90 Radiographic Systems Recalled for Ceiling Mount Failure

    Philips is recalling 33 DigitalDiagnost C90 radiographic imaging systems nationwide due to potential structural failure of ceiling-mounted units. Equipment may fall, creating injury risk.

    Product
    DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2024·2023-11-15

    Philips radiographic imaging system ceiling units risk of falling

    Philips EasyDiagnost Eleva DRF digital radiographic systems mounted on ceilings may fail and fall. 40 units nationwide are being recalled due to potential ceiling mount failure.

    Product
    EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0272-2024·2023-11-15

    DigitalDiagnost 4 Ceiling-Mounted X-Ray Units Recall for Fall Hazard

    Philips is recalling 13 DigitalDiagnost 4 Chest/Emergency radiographic imaging units due to a potential for ceiling-mounted units to fail and fall, posing injury risk.

    Product
    DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0273-2024·2023-11-15

    Philips DigitalDiagnost 4 radiographic systems risk of ceiling mounting failure

    Philips DigitalDiagnost 4 Flex/Value radiographic systems may fail when ceiling-mounted and fall, posing injury risk. Recall affects 92 units distributed nationwide.

    Product
    DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2024·2023-11-15

    DigitalDiagnost 4 Radiographic Systems Risk of Ceiling Mount Failure

    DigitalDiagnost 4 High Performance radiographic systems may fail and fall from ceiling mounts. The FDA recalls 366 units distributed nationwide.

    Product
    DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2024·2023-11-15

    DigitalDiagnost C90 radiographic system poses ceiling-mount failure risk

    Philips DigitalDiagnost C90 ceiling-mounted radiographic systems may fail and fall. FDA Class II recall affects 143 units nationwide; facilities should contact Philips.

    Product
    DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0277-2024·2023-11-15

    Radiographic Imaging System Recall Due to Ceiling Mount Failure Risk

    Philips DigitalDiagnost C90 Release 3 ceiling-mounted imaging system faces potential suspension failure risk. The FDA issued a Class II recall for nationwide-distributed Model 712025 due to risk of equipment falling.

    Product
    DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0280-2024·2023-11-15

    ProxiDiagnost N90 X-ray Systems Recalled for Potential Ceiling Mount Failure

    Philips is recalling 101 ProxiDiagnost N90 radiography and fluoroscopy systems due to potential failure of ceiling-mounted units, which could fall and cause injury.

    Product
    ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0278-2024·2023-11-15

    Philips DigitalDiagnost C90 radiography system ceiling-mount failure risk

    Philips is recalling two units of its DigitalDiagnost C90 Release 3.1 radiographic imaging system due to potential failure of ceiling-mounted units, which could fall.

    Product
    DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0271-2024·2023-11-15

    Philips CombiDiagnost R90 radiography systems recalled for ceiling mount failure

    Philips is recalling 46 CombiDiagnost R90 radiography systems nationwide due to potential ceiling mount failure that could allow suspended units to fall, posing an injury risk.

    Product
    CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2023·2023-10-11

    Philips EarlyVue VS30 Monitor Software Flaw Disables Respiration Alarms

    Philips is recalling the EarlyVue VS30 Vital Signs Monitor due to a software issue that prevents the device from alarming when a patient's respiration rate exceeds safe limits, potentially delaying critical clinical intervention.

    Product
    EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2023·2023-10-11

    EarlyVue VS30 Vitals Monitor May Fail to Alarm on Respiration Rate Violations

    A software defect in the Philips EarlyVue VS30 Vitals Monitor prevents alarms when respiration rate limits are violated, potentially delaying detection of dangerous breathing changes. Thirteen devices distributed in Massachusetts, Michigan, and Brazil are affected.

    Product
    EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2023·2023-09-27

    Philips Patient Information Center iX Software Crashes Delay Patient Monitoring

    Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.

    Product
    Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essential
    Category
    Medical Device
    Distribution
    Distributed nationwide