Philips North America, LLC

Complete recall history across all FDA and CPSC categories, 88 total recalls

Philips North America, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (88)

FDA medical device enforcement actions by Philips North America, LLC. Showing most recent 50.

Date Product Reason Class
Feb 7, 2022 The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providi... Update to instructions for use regarding the cleaning and disinfection proces... Class II
Mar 23, 2021 Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for moni... Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. ... Class II
Nov 19, 2020 Emission Computed Tomography System Image Process System - Product Usage: int... A software defect that has the potential to result in image misdiagnosis and ... Class II
Sep 14, 2020 Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Mode... The periodic Paddle Checks recommended in the Instructions for Use for Steril... Class II
Sep 14, 2020 Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model ... The periodic Paddle Checks recommended in the Instructions for Use for Steril... Class II
Jul 16, 2020 Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M35... The therapy switch may fail, resulting in the device exhibiting the following... Class II
Jun 30, 2020 IntelliVue MX700 patient monitor, model no. 865241 Some Intellivue MX700/MX800 Patient Monitors were delivered with defective po... Class II
Jun 30, 2020 IntelliVue MX800 patient monitor, model no. 865240 Some Intellivue MX700/MX800 Patient Monitors were delivered with defective po... Class II
Jun 25, 2020 IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.1... The device may experience an interruption of gas measurement due to a firmwar... Class II
Jun 18, 2020 Phillips Charging Station, Product #: 989803191021 - Product Usage: This char... A problem has been detected with the Philips LI-Polymer rechargeable battery ... Class II
Jun 18, 2020 Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Prod... A problem has been detected with the Philips LI-Polymer rechargeable battery ... Class II
Jun 18, 2020 Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module... A problem has been detected with the Philips LI-Polymer rechargeable battery ... Class II
Jun 8, 2020 Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lnte... Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Mo... Class II
Jun 2, 2020 EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagn... Thermo switches in the main power supply for the system may be incorrectly in... Class II
May 19, 2020 Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The Su... Philips has identified a Philips SureSigns VM1 monitor in the possession of a... Class II
Apr 27, 2020 Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A,... HeartStart XL MonitorlDefibrillators may not have been included in prior fiel... Class II
Apr 23, 2020 ProxiDiagnost N90, UDI 706100 The thermo switches in the three-phase transformer, which normally aid in pow... Class II
Apr 21, 2020 Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product ... HeartStart XL MonitorlDefibrillators may not have been included in prior fiel... Class II
Apr 20, 2020 Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an... Internal Paddles may wear over time and may not be safe or ready for use, unl... Class II
Apr 13, 2020 Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumog... The labeling of the Philips Chest Pneumograph does not include a statement in... Class II
Apr 13, 2020 Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The c... The labeling of the Philips Chest Pneumograph does not include a statement in... Class II
Apr 13, 2020 Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product U... The rotary therapy selector switch may fail, resulting in unexpected device b... Class II
Apr 10, 2020 Philips Zenition 50, System code 718096 - Product Usage: The devices are used... When strain relief is lost at the stand side of the Stand MVS Trolley Cable, ... Class II
Apr 10, 2020 HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a componen... Damaged ESD bags used for storing components in Processor PCA Replacement Kits Class II
Apr 10, 2020 Philips Zenition 70, System code 718133 - Product Usage: The devices are used... When strain relief is lost at the stand side of the Stand MVS Trolley Cable, ... Class II
Apr 7, 2020 Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 72001... If the shaft breaks due to material fatigue, the trauma arm can fall down and... Class II
Apr 6, 2020 Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model ... The bolt affixing the cooling unit to the rotor was not tightened to specific... Class II
Apr 6, 2020 Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI ... The bolt affixing the cooling unit to the rotor was not tightened to specific... Class II
Apr 6, 2020 Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 The bolt affixing the cooling unit to the rotor was not tightened to specific... Class II
Apr 3, 2020 Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1... When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGui... Class II
Mar 5, 2020 Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidan... No torque was specified for the four screws that connect the gearbox and the ... Class II
Mar 5, 2020 TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service N... The ECG signal from patients being monitored using a Philips TRx4841A and TRx... Class II
Mar 5, 2020 TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System ... The ECG signal from patients being monitored using a Philips TRx4841A and TRx... Class II
Feb 26, 2020 HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M353... Philips has received a number of reports of HeartStart MRx Monitor/Defibrilla... Class II
Feb 20, 2020 Expression MR400 MRI Patient Monitoring System Model Number: 866185 Softwa... Menu selections for users to access the oxygen (O2) sensor calibration were c... Class II
Jan 14, 2020 Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips H... M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" cond... Class II
Jan 13, 2020 Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. Th... if an AAA battery is inserted in the recorder and a user attempts to start i... Class II
Dec 30, 2019 Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 ... A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 30, 2019 Allura CV20, system code 722031 A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 30, 2019 Poly G Integris H5000, System code 72246 A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 30, 2019 MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708... A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 30, 2019 Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system c... A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 30, 2019 OmniDiagnost Eleva System codes 708028 708027 A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 30, 2019 UroDiagnost Eleva, system code 708033 A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 30, 2019 Cardio Vascular-Allura Centron, system code 722400 A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 30, 2019 Integris Allura 9, system codes 722018 722021 A capacitor inside the converter of the Velara X-ray generator may fail after... Class II
Dec 23, 2019 VesselNavigator application used with Philips Azurion (Azurion 7 Series) Soft... Due to a software defect, when a digital subtraction angiography (DSA) is exp... Class II
Nov 20, 2019 ProxiDiagnost N90 Unexpected increase in peak tube potential (kV) will lead to an increased pat... Class II
Oct 16, 2019 HeartStart XL+ Defibrillator/Monitor, Model 861290 The rotary therapy selector switch may fail, resulting in unexpected device b... Class II
Oct 3, 2019 HeartStart XL+ Defibrillator/Monitor, Model 861290 Device may fail to turn on or unexpectedly attempt to restart, rendering it u... Class II

View all 88 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.