Philips North America, Llc
Andover, MA
This page shows every FDA and USDA recall linked to Philips North America, Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
88
Total Recalls
2017
First Recall
2022
Most Recent
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of...
Mar 23, 2021
· Device
Terminated
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicin...
Nov 19, 2020
· Device
Terminated
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M...
Sep 14, 2020
· Device
Terminated
Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A,...
Sep 14, 2020
· Device
Terminated
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3...
Jul 16, 2020
· Device
Terminated
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
Jul 10, 2020
· Device
Terminated
IntelliVue MX700 patient monitor, model no. 865241
Jun 30, 2020
· Device
Terminated
IntelliVue MX800 patient monitor, model no. 865240
Jun 30, 2020
· Device
Terminated
IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391,...
Jun 25, 2020
· Device
Active
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expressio...
Jun 18, 2020
· Device
Terminated
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expre...
Jun 18, 2020
· Device
Terminated
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used i...
Jun 18, 2020
· Device
Terminated
Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model...
Jun 8, 2020
· Device
Terminated
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor...
May 19, 2020
· Device
Terminated
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
May 6, 2020
· Device
Terminated
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)0088483805954...
May 6, 2020
· Device
Terminated
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783,...
May 6, 2020
· Device
Terminated
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2...
Apr 29, 2020
· Device
Terminated
Philips HeartStart MRx Monitor/Defibrillators
Model numbers M3535A, M3536A, and M3536M - Product Usage: is f...
Apr 27, 2020
· Device
Terminated
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System
Codes 453564007261, 453564007271,...
Apr 23, 2020
· Device
Terminated
ProxiDiagnost N90, UDI 706100
Apr 23, 2020
· Device
Terminated
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411...
Apr 23, 2020
· Device
Terminated
Philips HeartStart XL Monitor/Defibrillators
Model number: M4735A - Product Usage: is for use in the hospital...
Apr 21, 2020
· Device
Terminated
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible moni...
Apr 20, 2020
· Device
Terminated
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred t...
Apr 13, 2020
· Device
Terminated
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital...
Apr 13, 2020
· Device
Terminated
Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pne...
Apr 13, 2020
· Device
Terminated
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and vi...
Apr 10, 2020
· Device
Terminated
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and vi...
Apr 10, 2020
· Device
Terminated
HeartStart MRx Processor Board PCA Replacement Kits
453563478461, a component of the Philips HeartStart MRx M...
Apr 10, 2020
· Device
Terminated
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiog...
Apr 7, 2020
· Device
Terminated
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079
Image guidance in diagnostic, interventional an...
Mar 5, 2020
· Device
Terminated
HeartStart MRx Monitor/Defibrillators with model numbers M3535A
M3536A, M3536M, M3536MC, M3536M2, M3536M3, M35...
Feb 26, 2020
· Device
Terminated
Expression MR400 MRI Patient Monitoring System
Model Number: 866185
Software version number: 01.03.00, 01.04....
Feb 20, 2020
· Device
Terminated
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips A...
Feb 10, 2020
· Device
Terminated
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillat...
Jan 14, 2020
· Device
Terminated
Philips DigiTrak XT Holter Recorder Software version number
B.1 and C.2.
The DigiTrak XT Recorder is available...
Jan 13, 2020
· Device
Terminated
MultiDiagnost Eleva, System codes 722030
722016
722017
708032
708036
708034
708037
708038
Dec 30, 2019
· Device
Terminated
OmniDiagnost Eleva System codes 708028
708027
Dec 30, 2019
· Device
Terminated
Allura Exper FD Series. System codes
722003
722010
722022
722005
722011
722019
722001
722002
722006
722012
722...
Dec 30, 2019
· Device
Terminated
UroDiagnost Eleva, system code 708033
Dec 30, 2019
· Device
Terminated
Cardio Vascular-Allura Centron, system code 722400
Dec 30, 2019
· Device
Terminated
Poly G Integris H5000, System code 72246
Dec 30, 2019
· Device
Terminated
Allura CV20, system code 722031
Dec 30, 2019
· Device
Terminated
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Dec 30, 2019
· Device
Terminated
Integris Allura 9, system codes 722018
722021
Dec 30, 2019
· Device
Terminated
ProxiDiagnost N90
Nov 20, 2019
· Device
Terminated
HeartStart XL+ Defibrillator/Monitor, Model 861290
Nov 19, 2019
· Device
Terminated
HeartStart XL+ Defibrillator/Monitor, Model 861290
Oct 3, 2019
· Device
Terminated