Brand

Philips North America, Llc Recalls

260 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Philips North America, Llc.

260Total Recalls
34Critical
46.6MUnits Affected
Jan 7, 2026Most Recent
All Recalls

Every Philips North America, Llc Recall

Sorted by most recent. Click any recall for full details.

260 recalls
High RiskFDA
Philips North America Llc
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Medical Devices·4,811 affected·Nov 20, 2024
High RiskFDA
Philips North America Llc
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Medical Devices·301 affected·Nov 16, 2024
High RiskFDA
Philips North America Llc
dS Breast 16ch 1.5T
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
Mammotrak Interventional Coil 3.0T
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
Mammotrak Diagnostic Coil 1.5T
Diagnostic Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
dS Breast 7ch 3.0T
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
ST SENSE Breast Dx Coil
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
SENSE Breast Coil
Medical Devices·5,231 affected·Nov 4, 2024
High RiskFDA
Philips North America Llc
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal struc...
Diagnostic Devices·33 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal...
Diagnostic Devices·64 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal st...
Diagnostic Devices·8 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the inte...
Diagnostic Devices·3 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spect...
Diagnostic Devices·14 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal s...
Diagnostic Devices·33 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t...
Diagnostic Devices·32 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal...
Diagnostic Devices·63 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal struct...
Diagnostic Devices·48 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of ...
Diagnostic Devices·2 affected·Sep 3, 2024
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by heal...
Medical Devices·18 affected·Jun 28, 2024
High RiskFDA
Philips North America Llc
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by heal...
Medical Devices·4 affected·Jun 28, 2024
CriticalFDA
Philips North America Llc
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Num...
Medical Devices·729 affected·Jun 5, 2024
CriticalFDA
Philips North America Llc
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
Medical Devices·386 affected·May 3, 2024
High RiskFDA
Philips North America Llc
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 9897...
Medical Devices·590 affected·May 3, 2024
CriticalFDA
Philips North America Llc
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model N...
Diagnostic Devices·10 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
Medical Devices·328 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number...
Diagnostic Devices·509 affected·May 3, 2024
CriticalFDA
Philips North America Llc
SmartPath to dStream for 3.0T Model Number (REF): 782145
Medical Devices·3 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
Medical Devices·0 affected·May 3, 2024
High RiskFDA
Philips North America Llc
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 9897100...
Medical Devices·100 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model N...
Diagnostic Devices·56 affected·May 3, 2024
CriticalFDA
Philips North America Llc
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): ...
Diagnostic Devices·81 affected·May 3, 2024
CriticalFDA
Philips North America Llc
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (R...
Diagnostic Devices·2 affected·May 3, 2024
High RiskFDA
Philips North America Llc
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 9897100...
Medical Devices·1,348 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model ...
Diagnostic Devices·4 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF)...
Diagnostic Devices·200 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Achieva 1.5T Initial system Model Number (REF): 781178
Medical Devices·2 affected·May 3, 2024
CriticalFDA
Philips North America Llc
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 78...
Diagnostic Devices·2 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Numbe...
Diagnostic Devices·1 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF)...
Diagnostic Devices·1,585 affected·May 3, 2024
CriticalFDA
Philips North America Llc
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnost...
Diagnostic Devices·32 affected·Apr 22, 2024
CriticalFDA
Philips North America Llc
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagno...
Diagnostic Devices·19 affected·Apr 22, 2024
High RiskFDA
Philips North America Llc
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Medical Devices·358 affected·Apr 19, 2024
High RiskFDA
Philips North America Llc
The Oncology Essentials Package of the Spectral CT imaging system.
Medical Devices·12 affected·Mar 29, 2024
High RiskFDA
Philips North America Llc
Ingenia 1.5T S, Magnetic Resonance System.
Medical Devices·135 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 1.5T, Magnetic Resonance System.
Medical Devices·1,921 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Medical Devices·22 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 3.0T, Magnetic Resonance System.
Medical Devices·511 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
GYROSCAN T5-NT, Magnetic Resonance System.
Medical Devices·23 affected·Mar 12, 2024