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.

226–250 of 306

  • HighFDA (Devices)·Z-1356-2023·2023-04-19

    X-ray System Models 706100 and 706110 Electrical Fire Risk from Power Surge

    Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.

    Product
    ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2023·2023-04-19

    X-ray imaging system ceiling suspension may descend without adequate maintenance

    Philips DigitalDiagnost C50 ceiling suspensions may descend unexpectedly if annual preventive maintenance is not performed, potentially injuring patients and healthcare workers.

    Product
    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2023·2023-01-18

    Philips Fetal Spiral Electrode may break off during labor monitoring

    Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.

    Product
    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2023·2022-12-14

    Philips MR 7700 System Upgrade Recalled Due to Gradient Coil Fire Risk

    Philips is recalling the Upgrade to MR 7700 System (Model 782130) because the gradient coil may act as a heat source and produce smoke or fire. Affected units should not be operated until Philips provides further guidance.

    Product
    Philips Upgrade to MR 7700 System, Model Number 782130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2023·2022-12-14

    Philips Ingenia Elition X MR System Gradient Coil Fire and Smoke Hazard

    Philips is recalling 566 Ingenia Elition X MRI systems nationwide. The gradient coil may act as a heat source with the potential to produce smoke and/or fire.

    Product
    Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2023·2022-12-14

    Philips MRI System Gradient Coil May Produce Smoke or Fire

    Philips is recalling certain Ingenia Elition S MR Systems due to a potential fire or smoke hazard from the gradient coil. The affected units are distributed nationwide in the United States.

    Product
    Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2023·2022-12-14

    Philips MRI System Recall Due to Fire and Smoke Risk

    Philips SmartPath to Ingenia Elition X MR System models may produce smoke or fire due to gradient coil heat. Recall affects 566 units nationwide.

    Product
    Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2023·2022-12-14

    Philips MR 7700 System Recalled for Gradient Coil Fire Risk

    Philips is recalling 566 MR 7700 MRI systems nationwide. The gradient coil in these systems may overheat and produce fire or smoke.

    Product
    Philips MR 7700 System, Model Number 782120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0004-2023·2022-10-12

    Philips MR Patient Care Portal 5000 Units Recalled for Intermittent Audio Failure

    Philips has recalled MR Patient Care Portal 5000 desktop units (Model 453564792561) due to intermittent audio failure. The device may fail to produce audio, and standard troubleshooting does not reliably resolve the issue.

    Product
    MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1563-2022·2022-09-07

    Philips Radiography System Firmware Defect Risks Incorrect Radiation Dose

    Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.

    Product
    DigitalDiagnost C50 1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2022·2022-05-18

    Philips Hemodynamic Application fails to set neonatal blood pressure mode

    The Philips Hemodynamic Application, Model 722463, may not automatically switch to neonatal mode for blood pressure monitoring, potentially applying excessive cuff pressure that could cause bruising, nerve damage, or bone deformity in newborns.

    Product
    Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0881-2022·2022-04-13

    Philips HeartStart HS1 AED Pads: Potential Gel Separation Defect

    Philips is recalling adult Smart PADS cartridges for HeartStart HS1 defibrillators due to potential gel separation from the pad backing. Affected pads may have reduced gel contact, potentially affecting device performance.

    Product
    Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2022·2022-04-13

    Philips Allura and Azurion X-ray systems may display incorrect previous images

    Philips Allura and Azurion X-ray systems running StentBoost Live R2.0 may display images from previous scans or other patients due to a software defect. 338 units are affected and globally distributed.

    Product
    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2022·2022-04-13

    Philips infant/child defibrillator pads recalled for gel separation defect

    Philips is recalling 331,712 infant and child defibrillator pads worldwide due to potential gel separation from the pad backing. The gel may fold onto itself or separate nearly completely, leaving reduced surface coverage on the pad.

    Product
    Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2022·2022-03-16

    Philips X-ray System Cooling Leak Poses Fire Risk

    Philips Allura CV20 X-ray systems with certain Laird chillers may leak cooling liquid onto electrical components, potentially causing fire or smoke. Affected systems should not be operated until the issue is addressed.

    Product
    Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2022·2022-03-16

    Philips Allura Xper X-ray systems cooling system leak poses fire risk

    Philips Allura Xper interventional X-ray systems may experience cooling liquid leaks that could drip on electrical components, creating risk of fire, smoke, or burning odors. No injuries have been reported.

    Product
    Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2022·2022-02-09

    Philips eCareManager versions recalled due to unapproved Sentry Score software

    Philips is recalling certain versions of eCareManager software because the Sentry Score feature was not approved by FDA prior to distribution. Users should contact Philips for updated information.

    Product
    eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2022·2022-01-26

    Cardinal Infant Heel Warmer recalled due to unapproved labeling changes

    Philips North America recalls Cardinal Infant Heel Warmers because labeling was changed without FDA approval. The devices cannot be sold or distributed without new FDA clearance.

    Product
    Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0507-2022·2022-01-26

    Heel Snuggler devices recalled for labeling changes without FDA approval

    Philips North America recalled approximately 2.5 million Heel Snuggler units because labeling was modified after FDA clearance without obtaining updated regulatory approval.

    Product
    Heel Snuggler, Reference # 989805603411 99047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2022·2022-01-26

    Medichoice Infant Heel Warmer recalled due to unapproved labeling changes

    Philips is recalling 2,925,800 Medichoice Infant Heel Warmer units because labeling was modified beyond the scope of FDA clearance. The devices cannot be sold without new 510(k) approval.

    Product
    Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0505-2022·2022-01-26

    Medical Device Mattress Recalled for Labeling Non-Compliance with FDA Requirements

    Philips is recalling 141,750 Infa-Therm Transport Mattresses because modified labeling does not comply with FDA clearance requirements. The devices cannot be distributed or sold without new FDA clearance.

    Product
    Infa-Therm Transport Mattress, Reference Number 989805616831 1015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2022·2022-01-26

    Infant Heel Warmers Recalled for Unauthorized Labeling Changes

    Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.

    Product
    Infant Heel Warmers w/strap, Reference # 989805603201 1223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2022·2022-01-19

    Philips Azurion X-ray System recalled for startup and emergency stop failures

    Philips recalls 10 Azurion interventional X-ray systems due to intermittent startup communication failures and emergency stop recovery issues that could prevent system restart and movement functionality.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2022·2022-01-19

    Philips wireless footswitches for Allura Xper and Azurion X-ray systems recalled for connection issues

    Philips wireless footswitches used with Allura Xper and Azurion X-ray systems may experience connection issues that interrupt fluoroscopic imaging during patient procedures. The recall affects 1,971 systems distributed worldwide.

    Product
    Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2022·2021-12-29

    Philips Allura Xper FD Ceiling Monitors Risk Falling Due to Loose Screws

    Set screws on ceiling-mounted extra monitors can loosen, causing monitors to fall and potentially injure patients, staff, or service technicians.

    Product
    Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013
    Category
    Medical Device
    Distribution
    Distributed nationwide