The Recall Desk

Manufacturer

Philips North America Llc

306 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 306

  • 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-1839-2024·2024-05-29

    Philips Achieva 3.0T MRI System Recall: Fire Hazard Risk

    Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.

    Product
    Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
    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-1871-2024·2024-05-29

    CT Scanner Component Fracture Risk in Incisive System

    Philips Incisive CT scanner systems may have a defective metal mounting box that could fracture and expel fragments during operation. Eighteen units are affected nationwide.

    Product
    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
    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-1849-2024·2024-05-29

    MRI Scanner Terminal Connection Fire and Smoke Risk

    Philips Ingenia 3.0T CX MRI scanners may experience loose terminal connections in the global Mains Distribution Unit (g-MDU) that could create fire or smoke hazards. The recall affects 350 units distributed worldwide.

    Product
    Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
    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-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-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-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-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-1836-2024·2024-05-29

    Philips Achieva 1.5T MR Systems Electrical Connection Fire Hazard

    Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.

    Product
    Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
    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-1857-2024·2024-05-29

    Philips MR System 1.5T Marlin MRI devices recalled due to fire hazard

    Philips is recalling 10 MR System 1.5T Marlin MRI devices worldwide due to a fire and smoke hazard. A loose electrical connection in the mains distribution unit may create a hotspot that causes smoke or fire in hospital technical rooms.

    Product
    MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2024·2024-05-29

    Medical Device Mains Distribution Unit Recall Due to Fire Risk

    The Evolution upgrade 3.0T mains distribution unit is being recalled because its L3 terminal connection may become loose, creating a hotspot that could cause fire or smoke in hospital technical rooms.

    Product
    Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
    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-1872-2024·2024-05-29

    Philips Incisive CT Scanner Metal Mounting Box May Expel Fragments

    A metal mounting box on the rotating scanner in the Philips Incisive CT system may become damaged and contact other components, potentially expelling fragments at low velocity. This recall affects 155 units distributed nationwide.

    Product
    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2024·2024-05-29

    Philips Panorama HFO MR Systems Loose Terminal Connection May Create Fire Hazard

    Philips Panorama HFO MR diagnostic imaging systems (Model 781350) contain a loose terminal connection in the mains distribution unit that may create a hotspot and cause smoke or fire. Approximately 118 units are affected worldwide.

    Product
    Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1865-2024·2024-05-29

    Philips dStream MR System Terminal Connection May Become Loose and Cause Fire

    Philips is recalling its Upgrade dStream MR system due to a potential fire hazard. A loose terminal connection in the g-MDU may create a hotspot causing smoke or fire.

    Product
    Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127
    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-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-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-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-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