The Recall Desk

Manufacturer

Philips North America Llc

302 recalls in our database name Philips North America Llc 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.

126–150 of 302

  • HighFDA (Devices)·Z-1861-2024·2024-05-29

    Philips Medical Device Recalled for Fire Hazard in Electrical Connection

    Philips is recalling the SmartPath to dStream for 3.0T medical device due to a loose electrical connection in the mains distribution unit that may cause smoke or fire in hospital technical rooms. Three units are affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2024·2024-05-29

    Philips Achieva 3.0T PET imaging device poses potential fire hazard

    A loose terminal connection in the power distribution unit of Philips Achieva 3.0T TX PET imaging systems may create an electrical hotspot, potentially causing smoke or fire. The device is distributed worldwide.

    Product
    Achieva 3.0T TX for PET Model Number (REF): 781479
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2024·2024-05-29

    MRI System Recalled Due to Loose Terminal Connection Fire Hazard

    Philips Ingenia Elition X- MRI systems have a loose terminal connection in the power distribution unit that may create a hotspot and cause smoke or fire in hospital settings. No injuries have been reported.

    Product
    Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1840-2024·2024-05-29

    Medical MR System Electrical Terminal Connection May Create Fire Hazard

    A Philips Achieva 3.0T for PET MR diagnostic system (Serial 43006) may have a loose mains distribution unit terminal that could overheat and cause smoke or fire.

    Product
    Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2024·2024-05-29

    Philips MR 5300 magnetic resonance systems' mains distribution unit may ignite

    Philips has recalled 81 MR 5300 MRI systems worldwide due to a loose electrical connection that may overheat and cause fire or smoke in hospital technical rooms.

    Product
    MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2024·2024-05-29

    Philips Intera 1.5T MRI System Mains Connection Defect Poses Fire Risk

    Philips is recalling 200 Intera 1.5T MRI systems worldwide due to loose mains distribution unit connections that may cause electrical hotspots, creating fire and smoke hazards in hospital technical rooms.

    Product
    Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2024·2024-05-29

    Philips MRI System Recall: Loose Electrical Terminal May Cause Fire

    Philips MRI diagnostic systems are recalled because a loose electrical connection in the g-MDU unit may create a hotspot, potentially causing fire and smoke in hospital technical areas.

    Product
    SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2024·2024-05-29

    Magnetic Resonance System Loose Terminal Connection May Cause Fire

    Philips MR RT imaging systems may have loose electrical connections that could cause smoke or fire in hospital technical rooms. Two units with serial numbers 45 and 47 are affected worldwide.

    Product
    MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2024·2024-05-29

    Medical Imaging System Recalled Due to Fire Risk from Loose Connection

    Philips has recalled 81 Marlin 1.5T MR diagnostic systems due to a loose g-MDU terminal connection that may create a fire hazard in hospital technical rooms.

    Product
    Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2024·2024-05-29

    Philips Recalls Ingenia 3.0T MR Systems for Loose Mains Terminal Fire Hazard

    Philips is recalling 1,517 Ingenia 3.0T magnetic resonance (MR) systems due to a potentially loose terminal connection in the mains distribution unit that may create a hotspot and cause fire or smoke.

    Product
    Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2024·2024-05-29

    Philips Sonalleve MR HIFU 3.0T diagnostic system fire risk recall

    Philips is recalling 4 Sonalleve MR HIFU 3.0T diagnostic systems worldwide due to loose electrical connections in the mains distribution unit that may create fire hazards in hospital settings.

    Product
    Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2024·2024-05-29

    MR Imaging System Recall for Loose Electrical Terminal Connection Fire Risk

    Philips AchievaXR MR systems may have loose terminal connections in the power distribution unit that could create hotspots and cause smoke or fire. The FDA has recalled 35 affected units worldwide.

    Product
    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2024·2024-05-29

    Philips Magnetic Resonance System MR RT Upgrades Recalled for Fire Risk

    Philips is recalling MR RT Upgrades Magnetic Resonance diagnostic systems due to a loose terminal connection in the mains distribution unit that could cause smoke or fire. Two units with serial numbers 70980 and 71569 are affected worldwide.

    Product
    MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2024·2024-05-29

    Philips MRI System Recalled for Potential Fire in Power Distribution Unit

    Philips is recalling 2 Achieva 1.5T MRI systems worldwide due to a potential loose connection in the power distribution unit that could cause smoke or fire in hospital technical rooms.

    Product
    Achieva 1.5T Initial system Model Number (REF): 781178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1843-2024·2024-05-29

    Evolution 1.5T MR Systems: Loose Terminal Connection Fire Risk

    Philips Evolution 1.5T MR systems may have loose g-MDU terminal connections that could create electrical hotspots and cause fires. The recall affects 56 units distributed worldwide.

    Product
    Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1846-2024·2024-05-29

    Philips Ingenia MR Systems Recalled for Fire Risk From Loose Connector

    Philips is recalling Ingenia 1.5T CX Magnetic Resonance systems due to a loose power distribution connection that may create a fire hazard in hospital technical rooms.

    Product
    Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2024·2024-05-29

    Philips Achieva 1.5T MR Systems: Loose Terminal Connection Fire Risk

    Philips is recalling Achieva 1.5T MR diagnostic systems worldwide due to a potential loose connection in the mains distribution unit that could create a hotspot and cause smoke or fire in hospital technical rooms.

    Product
    Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2024·2024-05-22

    Philips Patient Information Center iX Software: Event Catalog Data Loss Recall

    Philips Patient Information Center iX software version 4.x fails to properly save or transfer event catalog information, risking data loss in healthcare facilities. The FDA issued a Class II recall affecting 358 units globally.

    Product
    Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2024·2024-05-22

    MRI System Software May Fail to Warn of Inadequate Ventilation

    Philips Ingenia 1.5T MRI systems with software R5.7.1 may not provide adequate warning for low ventilation conditions, potentially causing increased patient body temperature or burning sensation.

    Product
    Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2024·2024-05-22

    Philips Ingenia 3.0T MR Systems May Not Warn of Low Ventilation Settings

    Philips Ingenia 3.0T MR systems with software R5.7.1 may fail to warn about low ventilation, potentially causing patient overheating or burning sensations. 19 units affected worldwide.

    Product
    Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2024·2024-05-08

    Philips Spectral CT Oncology Imaging System Recall: Laser Reflection Hazard

    Philips recalls 12 units of its Spectral CT Oncology Essentials system because a marking laser could reflect off the gantry cover, potentially causing misdiagnosis and incorrect patient treatment.

    Product
    The Oncology Essentials Package of the Spectral CT imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2024·2024-05-01

    Philips Patient Information Center iX UPS devices recalled for potential power failure

    Philips is recalling certain Patient Information Center iX Uninterruptable Power Supply devices due to potential power supply failures that could cause the monitoring system to shut down, risking delays in detecting patient condition changes.

    Product
    Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1575-2024·2024-04-24

    Philips MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips is recalling 347 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed, potentially compromising patient support stability during use.

    Product
    Intera 1.5T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2024·2024-04-24

    Philips Intera 1.5T MRI System Patient Support Table Installation Defect

    Philips is recalling certain Intera 1.5T MRI systems because the patient support table floor plate may be incorrectly installed, which could affect patient safety.

    Product
    Intera 1.5T Omni/Stellar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2024·2024-04-24

    Philips Intera 0.5T MRI System Patient Table Floor Plate Installation Defect

    Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.

    Product
    Intera 0.5T Standard, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide