The Recall Desk

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

192 recalls in our database name PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 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.

76–100 of 192

  • HighFDA (Devices)·Z-2624-2025·2025-10-01

    Medical imaging system recalled due to component deterioration affecting motorized positioning

    Philips Allura Xper FD10/10 X-ray systems may lose motorized positioning due to internal component deterioration. Manual positioning and imaging functions remain available.

    Product
    Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2025·2025-10-01

    Philips Allura Xper FD20 OR Table Motorized Movements May Fail

    Philips Allura Xper FD20 operating room tables may lose motorized movement capability due to internal component deterioration. Manual positioning and imaging functions remain available.

    Product
    Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2025·2025-10-01

    X-ray Fluoroscopy System Motorized Movement Failure from Internal Component Deterioration

    Allura Xper FD20 X-ray fluoroscopy systems may experience internal component deterioration, causing loss of motorized movements. Manual positioning and imaging functionality remain available.

    Product
    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2025·2025-10-01

    Philips Allura Xper FD20 Biplane System Motorized Component Deterioration

    Philips Allura Xper FD20 biplane X-ray systems may experience deterioration of internal components, causing loss of motorized movements. Manual movements and imaging functionality remain available.

    Product
    Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2025·2025-10-01

    Philips surgical table motorized movement malfunction due to component deterioration

    Philips Allura Xper FD10 operating room tables may experience motorized movement failure due to internal component deterioration. Manual positioning and imaging functions remain operational.

    Product
    Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2025·2025-10-01

    Philips Allura Xper FD20 Operating Room Table Motorized Movement Failure

    Philips Allura Xper FD20 operating room tables may lose motorized movement capability due to internal component deterioration. Manual positioning and imaging remain available.

    Product
    Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2630-2025·2025-10-01

    Philips Allura Xper FD20/20 X-Ray System: Motorized Movement Malfunction Risk

    Philips is recalling 75 Allura Xper FD20/20 X-ray systems worldwide due to potential deterioration of internal components, which may disable motorized movements. Manual movements and imaging capabilities remain functional.

    Product
    Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2634-2025·2025-10-01

    Philips OR Table motorized movements may fail due to component deterioration

    Philips Allura Xper FD20/15 OR Tables may lose motorized movements due to deterioration of internal components including battery, hard drive, and power supply. Manual movements and imaging functionality remain available.

    Product
    Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2632-2025·2025-10-01

    X-ray imaging system motorized positioning may fail due to component deterioration

    Allura Xper FD20/10 X-ray imaging systems may lose motorized positioning due to internal component deterioration. Manual operation and imaging remain functional.

    Product
    Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2635-2025·2025-10-01

    Fluoroscopy System Component Deterioration May Disable Motorized Movements

    Philips Allura CV20 fluoroscopy systems may lose motorized movement capability due to deterioration of internal components (battery, hard drive, power supply). Imaging and manual positioning remain available.

    Product
    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2631-2025·2025-10-01

    Philips Allura Xper FD20/20 Operating Room Table Motorized Movement Failure

    Philips Allura Xper FD20/20 OR tables may lose motorized movement capability due to internal component deterioration. Manual positioning and imaging functions remain available. FDA Class II recall affects 3 units outside the United States.

    Product
    Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2623-2025·2025-10-01

    Philips Allura Xper FD10 X-ray Systems Recalled for Component Deterioration

    Philips is recalling the Allura Xper FD10 imaging system due to internal component deterioration that can disable motorized movements. Manual controls and X-ray imaging functionality remain available.

    Product
    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2025·2025-10-01

    Philips X-ray Imaging System Motorized Functions May Fail Due to Component Deterioration

    Philips Allura Xper FD20/15 X-ray imaging systems may lose motorized positioning due to internal component deterioration. Manual controls and imaging functionality remain available.

    Product
    Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2543-2025·2025-09-17

    Philips IntelliSpace Cardiovascular Software displays outdated clinical information

    Philips IntelliSpace Cardiovascular Software 8.0.0.4 displays outdated information due to a software issue. Four units are distributed nationwide across Georgia, North Carolina, and Texas.

    Product
    IntelliSpace Cardiovascular, Software 8.0.0.4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2025·2025-09-10

    Philips Azurion and Allura imaging systems may shut down during power loss

    Philips Azurion and Allura medical imaging systems configured with certain 1-Phase power supplies may shut down or fail to start if power is lost. The recall affects approximately 1,861 units distributed worldwide.

    Product
    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Az
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2504-2025·2025-09-10

    Philips Allura Xper X-Ray Systems Recalled for Potentially Missing Component

    Philips is recalling 192 Allura Xper Series interventional fluoroscopic X-ray systems because an air baffle component may be missing from some units. The systems have been distributed in multiple U.S. states and internationally.

    Product
    Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. All
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2025·2025-09-10

    Philips Allura Imaging Systems May Shut Down During Power Loss Events

    Philips Allura medical imaging systems configured with certain power supplies may shut down or fail to start if power is lost, potentially disrupting patient care. Affected facilities should contact Philips to verify configuration and arrange remediation.

    Product
    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2025·2025-08-06

    Philips Allura X-ray Systems Software Issue Causes Temporary Imaging Loss

    Philips Allura R8.2.x fluoroscopy systems may experience temporary loss of X-ray imaging functionality due to a software issue. The recall affects 4,508 units distributed worldwide.

    Product
    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2134-2025·2025-07-30

    Philips Azurion 7 M20 X-Ray System C-Arm Gearbox Bolts May Loosen

    Philips is recalling Azurion 7 M20 fluoroscopic X-ray systems due to potential loosening of bolts connecting the gearbox to the C-arm mounting flange. No injuries have been reported.

    Product
    Azurion 7 M20. Fluoroscopic X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2025·2025-06-18

    Philips Azurion X-ray imaging systems affected by software communication defect

    A software communication issue in Philips Azurion X-ray imaging systems can cause loss of imaging functionality during use, potentially delaying critical treatment for emergency patients.

    Product
    Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: Al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2025·2025-05-21

    Philips Intera 1.5T MRI machines: Quadrature coil seal failure risk

    Philips is recalling 26 Intera 1.5T MRI machines due to potential adhesive failure in the Quadrature Body Coil seal, which may create sharp edges that could cause skin injuries or hair entanglement during patient scanning.

    Product
    Intera 1.5T Omni/Stellar, Model Number: 781104;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2025·2025-05-21

    Philips Intera 0.5T MRI Scanner Recall Due to Sharp Coil Seal Edges

    Philips has recalled 14 Intera 0.5T MRI scanners due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges that could injure patients during scanning.

    Product
    Intera 0.5T Standard, Model Number: 781101;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2025·2025-05-21

    Philips Intera MRI Coil Seal Failure May Cause Patient Injury

    The Quadrature Body Coil seal adhesive on Philips Intera 1.5T MRI systems may fail, creating sharp edges that could injure patients during scanning, causing abrasions, lacerations, or tissue damage.

    Product
    Intera 1.5T Power/Pulsar, Model Number: 781105;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2025·2025-05-21

    MRI Scanner Body Coil Seal Adhesive Failure Creates Risk of Sharp Edges

    Philips Intera 1.5T MRI scanners may have defective quadrature body coil seals. The adhesive can fail and create sharp edges that could injure patients during scanning.

    Product
    Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2025·2025-05-21

    Philips MRI Machine Coil Seal May Develop Sharp Edges

    Philips SmartPath MRI equipment may develop a failing coil seal that creates sharp edges, potentially causing skin injuries and lacerations to patients during scanning.

    Product
    SmartPath to dStream for 3.0T, Model Number: 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide