Philips North America, LLC
273 recalls on record · Latest: Dec 10, 2025
FDA Devices Moderate Dec 25, 2024
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
FDA Devices Moderate Dec 11, 2024
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
FDA Devices Moderate Dec 4, 2024
dS Breast 16ch 1.5T
FDA Devices Moderate Dec 4, 2024
Mammotrak Interventional Coil 3.0T
FDA Devices Moderate Dec 4, 2024
Mammotrak Diagnostic Coil 1.5T
FDA Devices Moderate Dec 4, 2024
dS Breast 7ch 3.0T
FDA Devices Moderate Dec 4, 2024
ST SENSE Breast Dx Coil
FDA Devices Moderate Dec 4, 2024
SENSE Breast Coil
FDA Devices Moderate Oct 16, 2024
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVu…
FDA Devices Moderate Oct 9, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 8661…
FDA Devices Moderate Oct 2, 2024
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the …
FDA Devices Moderate Oct 2, 2024
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…
FDA Devices Moderate Oct 2, 2024
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of t…
FDA Devices Moderate Oct 2, 2024
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structu…
FDA Devices Moderate Oct 2, 2024
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in…
FDA Devices Moderate Oct 2, 2024
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of …
FDA Devices Moderate Oct 2, 2024
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal …
FDA Devices Moderate Oct 2, 2024
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…
FDA Devices Moderate Oct 2, 2024
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the h…
FDA Devices Moderate Oct 2, 2024
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…
FDA Devices Moderate Aug 14, 2024
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care prof…
FDA Devices Moderate Aug 14, 2024
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care prof…
FDA Devices Moderate Aug 14, 2024
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care pro…
FDA Devices Moderate Aug 14, 2024
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care prof…
FDA Devices Critical Jul 3, 2024
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567…
FDA Devices Critical Jul 3, 2024
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 4535673…
FDA Devices Moderate Jun 12, 2024
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
FDA Devices Moderate Jun 12, 2024
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
FDA Devices Moderate Jun 12, 2024
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411
FDA Devices Moderate May 29, 2024
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
FDA Devices Moderate May 29, 2024
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF):…
FDA Devices Moderate May 29, 2024
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
FDA Devices Moderate May 29, 2024
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1…
FDA Devices Moderate May 29, 2024
SmartPath to dStream for 3.0T Model Number (REF): 782145
FDA Devices Moderate May 29, 2024
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
FDA Devices Moderate May 29, 2024
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF):…
FDA Devices Moderate May 29, 2024
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152…
FDA Devices Moderate May 29, 2024
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
FDA Devices Moderate May 29, 2024
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF)…
FDA Devices Moderate May 29, 2024
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
FDA Devices Moderate May 29, 2024
Achieva 1.5T Initial system Model Number (REF): 781178
FDA Devices Moderate May 29, 2024
MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
FDA Devices Moderate May 29, 2024
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781…
FDA Devices Moderate May 29, 2024
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 7812…
FDA Devices Moderate May 29, 2024
Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
FDA Devices Moderate May 29, 2024
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782…
FDA Devices Moderate May 22, 2024
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device R…
FDA Devices Moderate May 22, 2024
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
FDA Devices Moderate May 22, 2024
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device …
FDA Devices Moderate May 8, 2024