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.

76–100 of 423

  • ModerateFDA (Devices)·Z-1792-2025·2025-05-28

    Philips Upgrade to MR 7700 Medical Device Alignment Error Recall

    Philips is recalling the Upgrade to MR 7700 (Model 782130) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The misalignment could affect diagnostic accuracy.

    Product
    Product Name: Upgrade to MR 7700; Model Number: 782130;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1793-2025·2025-05-28

    Evolution Upgrade 1.5T imaging system alignment error recall

    Philips Evolution Upgrade 1.5T medical imaging systems may display alignment errors in cross-reference line functionality when reviewing images via MobiView application.

    Product
    Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1794-2025·2025-05-28

    Philips Evolution Upgrade 3.0T MRI Cross Reference Line Alignment Error

    Philips is recalling Evolution Upgrade 3.0T MRI systems (Models 782117 and 782143) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2025·2025-05-28

    Philips Ingenia 1.5T CX MRI System Alignment Error Potential

    Philips is recalling Ingenia 1.5T CX MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application. This could affect image interpretation.

    Product
    Product Name: Ingenia 1.5T CX; Model Number: 781262;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2025·2025-05-28

    Ingenia 3.0T MRI Systems Recalled for Image Alignment Errors

    Philips is recalling certain Ingenia 3.0T MRI systems worldwide due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2025·2025-05-28

    Philips Ingenia Elition S MRI System Alignment Error Recall

    Philips is recalling certain Ingenia Elition S MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

    Product
    Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2025·2025-05-14

    Philips Microstream Advance Neonatal-Infant CO2 Filter Line Adapter Disconnection Risk

    Philips is recalling Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines and related products because the adapter may be difficult or impossible to disconnect from the endotracheal tube.

    Product
    Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1660-2025·2025-04-30

    Philips Brilliance CT Big Bore X-Ray System Gantry Motion Collision Hazard

    Philips is recalling Brilliance CT Big Bore computed tomography systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.

    Product
    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2025·2025-04-30

    Zenition 50 Medical Imaging Devices Wireless Foot Switch Recall

    Philips is recalling Zenition 50 medical imaging devices because the wireless foot switch pedal may get stuck in the active position, causing unintended radiation emission.

    Product
    Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1582-2025·2025-04-30

    Veradius Unity wireless foot switch pedal may emit unintended radiation

    Philips North America is recalling Veradius Unity foot switch pedals that may become stuck in the active position, causing unintended radiation emission during medical procedures.

    Product
    Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1581-2025·2025-04-30

    Zenition 70 Radiological System Wireless Foot Switch Recall

    Philips is recalling Zenition 70 radiological systems with wireless foot switches that may stick in the active position when released, potentially causing unintended radiation emission during medical procedures.

    Product
    Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1554-2025·2025-04-23

    Philips DXR System DuraDiagnost Rel. 4 X-Ray System Collimator Fall Risk

    Philips is recalling 83 units of the DXR System, DuraDiagnost Rel. 4 stationary X-ray system due to potential for the collimator to fall if incorrectly installed. The defect could pose injury risk to patients or staff.

    Product
    Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2025·2025-04-23

    Philips DXR System X-Ray Equipment Collimator Fall Hazard Recall

    Philips is recalling certain DXR System DuraDiagnost 4.1 stationary X-ray systems due to a potential for the collimator to fall if installed incorrectly.

    Product
    Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2025·2025-02-12

    IntelliVue Patient Monitor MX550 May Fail to Alarm on Ventilator Disconnection

    Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.

    Product
    IntelliVue Patient Monitor MX550. Model Number: 866066
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1108-2025·2025-02-12

    Patient Monitor May Fail to Alert When Ventilator Disconnects

    Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.

    Product
    IntelliVue Patient Monitor MX450. Model Number: 866062
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1107-2025·2025-02-12

    Patient Monitor May Fail to Alarm on Ventilator Disconnect

    Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.

    Product
    IntelliVue Patient Monitor MX400. Model Number: 866060
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1109-2025·2025-02-12

    IntelliVue Patient Monitor MX500 may fail to generate critical alarms

    Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.

    Product
    IntelliVue Patient Monitor MX500. Model Number: 866064
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1106-2025·2025-02-12

    IntelliBridge EC10 Module may fail to alarm on ventilator disconnection

    The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.

    Product
    IntelliBridge EC10 Module. Model Number: 865115
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0686-2025·2024-12-25

    Philips Access Point Software Issue Risks Patient Data Loss

    Philips Smart-Hopping 2.0 Access Points may reset after 82 days, risking loss of patient data and network disconnections. No injuries have been reported.

    Product
    Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2025·2024-12-11

    Spectral CT Devices Pose Collision and Misdiagnosis Software Risks

    Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.

    Product
    Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2025·2024-12-04

    Philips SENSE Breast Coil Recall for Potential Patient Safety Hazard

    Philips is recalling 5,231 SENSE Breast Coils due to a potential patient safety hazard during scan preparation and performance. The FDA has not disclosed specific details about the nature of the risk.

    Product
    SENSE Breast Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2025·2024-12-04

    Philips Breast MRI System Recalled for Patient Safety Risk

    Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.

    Product
    dS Breast 7ch 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2025·2024-12-04

    Philips dS Breast 7ch 3.0T MRI Coil Recalled for Patient Safety Hazard

    Philips is recalling 5,231 dS Breast 7ch 3.0T breast MRI coils distributed nationwide due to a potential safety issue that may harm patients during scan preparation or scanning. The FDA classified this as Class II.

    Product
    dS Breast 7ch 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2025·2024-12-04

    Philips Achieva TX Interventional Coil 3.0T Recalled for Patient Safety Risk

    Philips recalls the Achieva TX Interventional Coil 3.0T (5,231 units) for a potential safety issue that may harm patients during MRI scan preparation or procedures.

    Product
    Achieva TX Interventional Coil 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2025·2024-12-04

    Philips Mammotrak Diagnostic Coil 3.0T Recall Due to Patient Safety Risk

    Philips is recalling 5,231 Mammotrak Diagnostic Coil 3.0T units due to a potential safety issue that could harm patients during MRI scan preparation or scanning.

    Product
    Mammotrak Diagnostic Coil 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide