The Recall Desk

Manufacturer

Philips North America

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

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.

26–50 of 126

  • HighFDA (Devices)·Z-1206-2026·2026-02-04

    Philips Ingenia 1.5T MRI Software Displays Incorrect Elastography Values

    Philips Ingenia 1.5T MRI systems with software versions R11.1 or R12.1 may display incorrect stiffness values when viewing MR Elastography images in medical imaging systems. Ten affected units have been identified worldwide.

    Product
    Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2026·2026-02-04

    MRI stiffness measurement errors in Philips Ingenia Elition X systems

    Philips is recalling Ingenia Elition X MRI systems due to potential errors in stiffness measurements displayed in elastography imaging. Affected users should verify measurement accuracy with clinical engineers.

    Product
    Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2026·2026-02-04

    MR Imaging System May Display Incorrect Stiffness Values

    Philips Ingenia Ambition S MR systems with software versions R11.1 or R12.1 may display incorrect tissue stiffness values when viewing MR Elastography data on PACS. Incorrect values could affect clinical interpretation.

    Product
    Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2026·2026-02-04

    Ingenia MR system may display inaccurate elastography stiffness values

    Philips Ingenia 3.0T CX MR imaging systems with software versions R11.1 and R12.1 may display inaccurate tissue stiffness values in PACS viewers, potentially affecting diagnostic accuracy.

    Product
    Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2026·2026-02-04

    Philips MRI systems may display incorrect elastography stiffness values

    Philips SmartPath to dStream 3.0T MRI systems with software versions R11.1 and R12.1 may display inaccurate stiffness values when viewing MR Elastography maps in PACS viewers.

    Product
    SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2026·2026-02-04

    Philips Ingenia Ambition X MR Systems Potential Stiffness Value Errors

    Philips is recalling 21 Ingenia Ambition X MR systems due to potential errors in MR Elastography stiffness values when viewing exported data in PACS systems. The inaccurate measurements could affect diagnostic accuracy.

    Product
    Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1211-2026·2026-02-04

    Philips Ingenia Elition S MR Systems May Display Incorrect Stiffness Values

    Philips recalled five Ingenia Elition S MR systems with software versions R11.1 and R12.1 due to potential stiffness value calculation errors. The issue affects elastography data displayed in PACS viewers worldwide.

    Product
    Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1156-2026·2026-01-28

    Medical Device Software Update Silently Changes Alert Settings Without User Notification

    A software update to Philips Patient Information Center iX modifies Mobile Event Notification filter settings without alerting users during upgrade. This could result in missed critical patient alerts to medical staff.

    Product
    Patient Information Center iX; Software Version Number: 4.5.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0597-2026·2025-12-17

    Philips Azurion 7 M20 fluoroscopic X-ray systems recalled for missing radiation safety spacer

    Philips recalled 110 Azurion 7 M20 fluoroscopic X-ray systems in the U.S. shipped without a required Source-to-Skin Distance Spacer. The missing component may prevent systems from meeting FDA radiation safety distance requirements.

    Product
    Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0165-2026·2025-10-22

    Cardiac Workstation 5000 recalled for electrical short from pinched wire

    Philips North America is recalling the Cardiac Workstation 5000 (Model 860439) due to a potential electrical short caused by a pinched power module wire. Approximately 28 units have been distributed nationwide.

    Product
    Cardiac Workstation 5000; Model Number: 860439;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2026·2025-10-22

    Cardiac Workstation 7000 recalled due to pinched power module wire

    Philips is recalling 29 units of the Cardiac Workstation 7000 due to a pinched power module wire inside the device housing that can cause an electrical short.

    Product
    Cardiac Workstation 7000; Model Number: 860441;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2209-2025·2025-08-06

    Philips Ingenia Ambition X MR Systems recalled due to fire hazard

    Philips is recalling 690 Ingenia Ambition X MR systems worldwide due to potential gradient coil component failures that could produce smoke or fire. Verify your device's model and serial number against the FDA recall list.

    Product
    Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2204-2025·2025-08-06

    MRI System Gradient Coil Defects May Produce Fire or Smoke

    Philips Ingenia 1.5T MRI systems are recalled due to potential gradient coil component failures that may produce smoke or fire. The recall affects 2,279 units distributed worldwide.

    Product
    Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2025·2025-08-06

    MRI System Gradient Coil May Produce Smoke or Fire

    Philips is recalling 93 MRI systems with defective gradient coil components that may produce smoke or fire due to component failure.

    Product
    Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2025·2025-08-06

    Philips MRI Systems Recalled for Fire and Smoke Risk

    Philips is recalling 50 Evolution Upgrade 3.0T MRI systems worldwide due to potential fire and smoke from gradient coil component failures.

    Product
    Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2025·2025-08-06

    Philips SmartPath MRI systems recalled due to potential fire hazard

    Philips is recalling 294 SmartPath to dStream MRI systems due to potential component failures in the gradient coil that could produce smoke and fire. No injuries have been reported.

    Product
    SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2025·2025-08-06

    Achieva 3.0T MRI Systems Recalled Due to Gradient Coil Fire Risk

    Philips North America is recalling Achieva 3.0T MRI systems due to potential gradient coil component failures that could produce smoke or fire. The recall affects 460 units distributed worldwide.

    Product
    Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2025·2025-08-06

    Philips MR System Gradient Coil Failure May Produce Fire or Smoke

    Philips is recalling certain SmartPath to Ingenia Elition X magnetic resonance imaging systems due to potential gradient coil component failures that could generate heat and produce smoke or fire. Approximately 33 units are affected worldwide.

    Product
    SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2025·2025-08-06

    Philips Ingenia Elition S MRI Systems Recalled for Fire Hazard

    Philips is recalling 242 Ingenia Elition S MRI systems worldwide due to potential gradient coil component failures that could produce smoke and fire. Affected facilities should immediately stop using the systems.

    Product
    Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2025·2025-08-06

    Philips MR 5300 MRI Systems Gradient Coil Fire and Smoke Risk

    Philips is recalling certain MR 5300 magnetic resonance imaging systems due to potential gradient coil component failures that could generate heat, smoke, or fire. The recall affects 551 units distributed worldwide, including the United States.

    Product
    MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2025·2025-08-06

    Philips MRI Systems Recalled for Gradient Coil Fire and Smoke Hazard

    Philips North America is recalling 136 Ingenia MRI systems due to potential gradient coil failures that could generate heat and produce smoke or fire. The affected units have been distributed worldwide.

    Product
    Ingenia 1.5T S Model Number (REF): 781347;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2025·2025-08-06

    MRI System Gradient Coil Component May Overheat and Produce Fire or Smoke

    Philips MRI systems with affected gradient coils may experience component failures that could produce smoke or fire. Fifteen units worldwide are affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2025·2025-08-06

    MRI System Gradient Coil May Produce Smoke or Fire

    Philips is recalling Intera 3.0T Quasar Dual MRI systems worldwide due to potential gradient coil failures that could generate smoke or fire.

    Product
    Intera 3.0T Quasar Dual Model Number (REF): 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2211-2025·2025-08-06

    MRI Gradient Coil Component Failure Risk: Potential Fire and Smoke Hazard

    Philips Ingenia Elition X MRI systems may have gradient coil component failures that could generate heat, smoke, and fire. Affected units were distributed worldwide including the United States.

    Product
    Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2025·2025-08-06

    Philips MR 7700 Imaging Systems Recalled for Potential Fire Hazard

    Philips is recalling MR 7700 imaging systems due to potential component failures in the gradient coil that may produce smoke and fire. The recall affects 82 units distributed worldwide.

    Product
    MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;
    Category
    Medical Device
    Distribution
    Distributed nationwide