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.

326–350 of 410

  • ModerateFDA (Devices)·Z-2811-2020·2020-08-26

    Philips Charging Station Recalled Due to Battery Charging Failure

    Philips is recalling charging stations for the Expression MR400 MRI system because the battery fails to charge due to poor electrical contact.

    Product
    Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronizati
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2812-2020·2020-08-26

    Philips Module Charger Recall for MRI Patient Monitoring System

    Philips is recalling Module Chargers used in the Expression MR400 MRI Patient Monitoring System because poor electrical contact prevents the lithium-polymer battery from charging.

    Product
    Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2810-2020·2020-08-26

    Philips MRI Patient Monitoring System Battery Recall for Charging Failure

    Philips is recalling 24,545 rechargeable Li-Polymer batteries used in the Expression MR400 MRI Patient Monitoring System. The batteries may fail to charge due to poor electrical contact.

    Product
    Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for sy
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2794-2020·2020-08-19

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure

    Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.

    Product
    Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel tra
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2689-2020·2020-07-29

    Philips IntelliVue G7m Anesthesia Gas Module Firmware Recall

    Philips is recalling 3,075 IntelliVue G7m Anesthesia Gas Modules due to a firmware issue that may interrupt gas measurement and display.

    Product
    IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2020·2020-07-15

    Philips M3015A Microstream CO2 Extension Recall for Incompatibility

    Philips is recalling M3015A Microstream CO2 Extensions because they are incompatible with IntelliVue X3 and MMX monitors, which may cause a loss of monitoring.

    Product
    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2020·2020-07-15

    Philips EasyDiagnost Eleva DRF X-ray System Recalled for Power Supply Defect

    Philips is recalling 52 EasyDiagnost Eleva DRF X-ray systems because incorrectly installed thermo switches in the main power supply may cause malfunction.

    Product
    EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2337-2020·2020-06-17

    Philips SureSigns VM1 Monitor Recalled Due to Unverified Manufacturing Records

    Philips is recalling a specific SureSigns VM1 patient monitor because it was not intended for commercial distribution and lacks manufacturing records.

    Product
    Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2245-2020·2020-06-10

    Philips Chest Pneumograph Recalled for Missing Natural Rubber Latex Labeling

    Philips is recalling 1,075 Chest Pneumograph units because the labeling fails to state that the product contains natural rubber latex.

    Product
    Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2244-2020·2020-06-10

    Philips Chest Pneumograph Recalled for Missing Latex Labeling

    Philips is recalling Chest Pneumograph accessories because the labeling does not state that the product contains natural rubber latex.

    Product
    Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2020·2020-06-03

    Philips HeartStart XL Monitor/Defibrillators Recalled for Missing Field Action Corrections

    Philips is recalling 130 HeartStart XL Monitor/Defibrillators because they may not have received required corrections from prior field actions.

    Product
    Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2020·2020-06-03

    Philips Recalls Sterilizable Defibrillator Internal Paddles Due to Wear Risk

    Philips is recalling 21,683 sets of sterilizable defibrillator internal paddles because they may wear over time and fail to deliver therapy if routine checks are not performed.

    Product
    Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2020·2020-06-03

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Missing Field Action Corrections

    Philips is recalling 260 HeartStart MRx Monitor/Defibrillators because some units may not have received required corrections from prior field actions.

    Product
    Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2053-2020·2020-05-27

    Philips HeartStart XL Defibrillator Recalled for Rotary Switch Failure

    Philips is recalling HeartStart XL Defibrillators because a faulty switch may prevent the device from turning on or delivering the correct shock energy.

    Product
    Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2064-2020·2020-05-27

    Philips HeartStart MRx Processor Board Replacement Kits Recalled for Damaged Bags

    Philips is recalling HeartStart MRx Processor Board PCA Replacement Kits because damaged ESD bags were used for storing components.

    Product
    HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2020·2020-05-20

    Philips Zenition 50 Medical Device Recalled for Electrical Contact Failure

    Philips is recalling 25 Zenition 50 devices because strain relief loss can cause electrical contacts to break, potentially exposing live parts or losing the video signal.

    Product
    Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1933-2020·2020-05-20

    Philips Zenition 70 Trolley Cable Recall for Electrical Contact Failure

    Philips is recalling 25 Zenition 70 systems because strain relief loss on the trolley cable can break electrical contacts, exposing live parts.

    Product
    Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1921-2020·2020-05-13

    Philips Brilliance iCT Computed Tomography Systems Recalled for Bolt Defect

    Philips North America, LLC is recalling 19 Brilliance iCT Computed Tomography X-Ray Systems because a bolt affixing the cooling unit to the rotor was not tightened to specification.

    Product
    Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1923-2020·2020-05-13

    Philips Brilliance IQon Spectral CT Recall for Cooling Unit Bolt Issue

    Philips is recalling two Brilliance IQon Spectral CT systems because a bolt on the cooling unit was not tightened to specification.

    Product
    Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1922-2020·2020-05-13

    Philips Brilliance iCT SP CT Scanner Recall Due to Bolt Issue

    Philips is recalling two Brilliance iCT SP CT scanners because a cooling unit bolt was not tightened to specification.

    Product
    Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1806-2020·2020-05-06

    Philips TraumaDiagnost X-Ray System Recalled Due to Potential Shaft Failure

    Philips North America is recalling 346 TraumaDiagnost X-Ray systems because a shaft may break due to material fatigue, causing the arm to fall and potentially injure patients or staff.

    Product
    Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide