The Recall Desk

Manufacturer

Philips North America, LLC

410 recalls in our database name Philips North America, LLC as the manufacturing or recalling firm.

What the numbers show

Total
410
Critical
2
Severe
26
Most recent
2026-09-09

Of the 410 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 26 (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.

351–375 of 410

  • HighFDA (Devices)·Z-1801-2020·2020-05-06

    Philips Azurion 7 M20 X-Ray System Recalled for Loose Screw Risk

    Philips is recalling 162 Azurion 7 M20 angiographic X-ray systems because unspecified torque on C-arm roll motor screws could cause them to become loose.

    Product
    Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2020·2020-05-06

    Philips Azurion 7 M20 XperGuide Software Recall for Incorrect Overlay Display

    Philips is recalling Azurion 7 M20 systems with XperGuide software because a software defect may display incorrect needle paths if the L-arm is mispositioned.

    Product
    Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1616-2020·2020-04-08

    Philips Recalls MRI Patient Monitoring Systems Due to Incorrect Calibration Instructions

    Philips is recalling 2,214 MRI Patient Monitoring Systems because the instructions for oxygen sensor calibration are incorrect for specific software versions.

    Product
    Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1499-2020·2020-03-25

    Philips Recalls HeartStart MRx Defibrillators Due to Internal Damage Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because internal damage from drops or shocks may prevent therapy delivery, even if the device appears undamaged.

    Product
    HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2020·2020-03-25

    Philips Allura Exper FD Series X-Ray Generator Recall

    Philips is recalling Allura Exper FD Series X-ray generators because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1487-2020·2020-03-25

    Philips Integris Allura X-ray Systems Recalled for Capacitor Failure

    Philips is recalling 70 Integris Allura 15 & 12 X-ray systems because a capacitor may fail, preventing image acquisition.

    Product
    Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1491-2020·2020-03-25

    Philips Velara X-ray Generator Recalled for Capacitor Failure

    Philips is recalling the Velara X-ray generator because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Poly G Integris H5000, System code 72246
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1493-2020·2020-03-25

    Philips Allura CV20 X-ray System Recalled for Capacitor Failure

    Philips is recalling 128 Allura CV20 X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Allura CV20, system code 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1494-2020·2020-03-25

    Philips Allura Centron X-ray System Recalled for Capacitor Failure

    Philips is recalling 87 Allura Centron X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    Cardio Vascular-Allura Centron, system code 722400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1489-2020·2020-03-25

    Philips MultiDiagnost Eleva X-ray System Recalled for Capacitor Failure

    Philips is recalling 534 MultiDiagnost Eleva X-ray systems because a capacitor may fail after electrical surges, preventing image acquisition.

    Product
    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2020·2020-03-04

    Philips Ambulance Parameter Extension Kit Recalled for ECG Signal Loss

    Philips is recalling 43 Ambulance Parameter Extension kits because they may cause ECG 'Leads Off' errors in hot, humid environments.

    Product
    Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1345-2020·2020-03-04

    Philips DigiTrak XT Holter Recorder Software Recall for Malfunction

    Philips is recalling DigiTrak XT Holter Recorders because a software defect causes the device to fail when an AAA battery is present.

    Product
    Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Config
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1272-2020·2020-02-26

    Philips HeartStart AEDs Recalled for Quality Standards Defect

    Philips is recalling 96 HeartStart AEDs because their Printed Circuit Assemblies were not manufactured or repaired to quality standards.

    Product
    Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1271-2020·2020-02-26

    Philips HeartStart FRx AED Recalled for Quality Standards Violation

    Philips is recalling 44 HeartStart FRx AED units because their Printed Circuit Assemblies were not manufactured or repaired according to quality standards.

    Product
    Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1145-2020·2020-02-19

    Philips VesselNavigator Software Recall for DSA Display Defect

    Philips is recalling VesselNavigator software due to a defect that displays digital subtraction angiography images without subtraction.

    Product
    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extension
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2020·2019-12-11

    Philips HeartStart XL+ Defibrillator Recall for Power-On Failure

    Philips is recalling 24,738 HeartStart XL+ Defibrillator/Monitor units because they may fail to turn on or restart, rendering them unable to return to a ready-for-use state.

    Product
    HeartStart XL+ Defibrillator/Monitor, Model 861290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0498-2020·2019-11-27

    Philips HeartStart XL+ Defibrillator Recall Due to Switch Failure

    Philips is recalling HeartStart XL+ Defibrillators because a faulty switch may cause the device to fail or deliver incorrect shock energy.

    Product
    HeartStart XL+ Defibrillator/Monitor, Model 861290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2547-2019·2019-09-25

    Philips IntelliVue Remote Antenna Cable Recalled for Incorrect Rating

    Philips is recalling IntelliVue 1.4 GHz Remote Antenna cables used with MX40 monitors because they lack the required rating for some installations.

    Product
    IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2488-2019·2019-09-18

    Philips Recalls Two HeartStart MRx Monitor/Defibrillators for Missing Corrections

    Philips North America, LLC is recalling two HeartStart MRx Monitor/Defibrillators because they may not have received applicable corrections from prior field actions.

    Product
    HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2495-2019·2019-09-18

    Philips 5-Lead ECG Set Recalled Due to Connector Thickness Issue

    Philips is recalling 5-Lead ECG sets because the connector thickness may prevent or impede I 2-Lead ECG measurements.

    Product
    Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2205-2019·2019-08-14

    Philips Azurion X-ray systems recalled for cold restart delays

    Philips is recalling Azurion interventional fluoroscopic X-ray systems because a cold restart may take up to 7 minutes, potentially delaying treatment.

    Product
    Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The
    Category
    Medical Device
    Distribution
    Distributed nationwide