The Recall Desk

Manufacturer

Philips Medical Systems Nederland B.V.

209 recalls in our database name Philips Medical Systems Nederland B.V. as the manufacturing or recalling firm.

What the numbers show

Total
209
Critical
2
Severe
20
Most recent
2026-08-19

Of the 209 recalls from Philips Medical Systems Nederland B.V. we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (10%) 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.

101–125 of 209

  • HighFDA (Devices)·Z-2628-2025·2025-10-01

    Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration

    Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.

    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-2632-2025·2025-10-01

    Allura Xper FD20/10 systems recalled over deterioration disabling motorized movement

    Philips Allura Xper FD20/10 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 45 units are affected.

    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-2624-2025·2025-10-01

    Philips Allura Xper FD10/10 X-Ray System Motorized Movement Failure Recall

    Philips Allura Xper FD10/10 X-ray systems may lose motorized movement capability due to deterioration of internal components including the CMOS battery, hard disk drive, or power supply unit. Imaging and manual movements remain functional.

    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
  • ModerateFDA (Devices)·Z-2633-2025·2025-10-01

    Allura Xper FD20/15 X-ray System Motorized Movement Component Deterioration

    Philips recalls Allura Xper FD20/15 X-ray systems due to potential deterioration of internal components that may disable motorized movements, though manual movements 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

    Cardiovascular software recalled because it may display outdated information

    IntelliSpace Cardiovascular software version 8.0.0.4 is recalled because of a software issue that results in the display of outdated information. 4 units are affected.

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

    Azurion imaging systems recalled because single phase UPS may fail on power loss

    Philips Azurion systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,861 units are affected.

    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-2503-2025·2025-09-10

    Interventional imaging systems recalled because single phase UPS may fail on power loss

    Philips Allura systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,006 units are affected.

    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
  • ModerateFDA (Devices)·Z-2504-2025·2025-09-10

    Fluoroscopic X-ray systems recalled over air baffle missing from internal PCs

    Philips Allura Xper interventional fluoroscopic X-ray systems are recalled because an air baffle component may be missing in some Nehalem FlexVision-2 PCs. 192 units are affected.

    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-2189-2025·2025-08-06

    Philips Allura R8.2.x systems may temporarily lose x-ray imaging functionality

    Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.

    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
  • HighFDA (Devices)·Z-2134-2025·2025-07-30

    Azurion 7 M20 C-arm gearbox mounting bolts may become loose

    The Azurion 7 M20 fluoroscopic x-ray system is being recalled because of the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. 78 units affected.

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

    Azurion R1.x and R2.x X-ray systems software communication issue

    Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.

    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-1779-2025·2025-05-21

    Philips Intera 1.5T R11 MRI System Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.5T R11 MRI systems because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could contact patients and cause skin injuries.

    Product
    Intera 1.5T R11, Model Number: 781170;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.5T Explorer/Nova Dual MRI scanners (Model 781108) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges that could contact patients during scanning and cause skin injuries.

    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 SmartPath to dStream 3.0T MRI Coil Adhesive Failure Recall

    Philips is recalling SmartPath to dStream 3.0T MRI systems (Model 782145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    SmartPath to dStream for 3.0T, Model Number: 782145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Body Coil Seal Failure Recall

    Philips is recalling 103 Intera 1.5T MRI scanners worldwide because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, bruises, lacerations, hair loss, or tissue injury to patients.

    Product
    Intera 1.5T Master/Nova, Model Number: 781106;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2025·2025-05-21

    Philips Intera 3.0T Quasar Dual MRI Scanner Coil Seal Adhesive Failure

    Philips is recalling the Intera 3.0T Quasar Dual MRI scanner (Model 781150) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 3.0T Quasar Dual, Model Number: 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Failure

    Philips is recalling the Intera 1.5T Omni/Stellar MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and cause patient injury. The loose seal during scanning could result in skin abrasions, bruises, lacerations, hair loss, or tissue damage.

    Product
    Intera 1.5T Omni/Stellar, Model Number: 781104;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner QBC Seal Adhesive Failure Risk

    Philips is recalling the Intera 1.5T Power/Pulsar MRI scanner because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 1.5T Power/Pulsar, Model Number: 781105;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1782-2025·2025-05-21

    Philips SmartPath dStream 1.5T MRI coil may create sharp edges

    Philips is recalling SmartPath to dStream 1.5T MRI units (Model 782146) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, lacerations, or tissue injury to patients.

    Product
    SmartPath to dStream for 1.5T, Model Number: 782146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2025·2025-05-21

    Philips Intera 0.5T Standard MRI System Quadrature Body Coil Seal

    Philips is recalling the Intera 0.5T Standard MRI system (Model 781101) because the Quadrature Body Coil seal adhesive may fail and 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-1773-2025·2025-05-21

    Philips Intera 1.0T MRI Quadrature Body Coil Seal Failure Recall

    Philips is recalling Intera 1.0T Power/Pulsar MRI systems (Model 781103) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and injure patients during scanning.

    Product
    Intera 1.0T Power/Pulsar, Model Number: 781103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2025·2025-05-21

    Philips Intera 1.0T MRI System Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.0T Omni/Stellar MRI systems (37 units: 3 in US, 34 internationally) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that can cause skin injuries during patient scanning.

    Product
    Intera 1.0T Omni/Stellar, Model Number: 781102;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1770-2025·2025-05-21

    Philips Enterprise 1.5T MRI Equipment Quadrature Body Coil Seal

    Philips is recalling Enterprise 1.5T MRI scanners (Model 781145) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Enterprise 1.5T, Model Number: 781145;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1781-2025·2025-05-21

    Philips Intera CV MRI Quadrature Body Coil Seal Adhesive Failure Recall

    Philips is recalling Intera CV MRI units (Model 781107) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning, including skin abrasions, lacerations, or tissue damage.

    Product
    Intera CV, Model Number: 781107;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2025·2025-05-21

    Philips Intera 1.5T MRI Quadrature Body Coil seal adhesive failure

    Philips is recalling Intera 1.5T MRI systems due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and contact patient skin during scanning.

    Product
    Intera 1.5T, Model Numbers: 781195 and 781295;
    Category
    Medical Device
    Distribution
    Distributed nationwide