Manufacturer

Philips North America Llc

306 recalls in our database name Philips North America Llc as the manufacturing or recalling firm.

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.

276–300 of 306

HighFDA (Devices)·Z-2414-2021·2021-09-15
MRI Tabletop Movement Malfunction in Manual Mode Affects Philips Ingenia Systems
Philips Ingenia 1.5T CX-a MRI systems may have a tabletop that fails to fully move in or out during manual operation, potentially delaying patient evacuation and treatment.
Product
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2420-2021·2021-09-15
Medical Device Alert: Philips Ingenia MRI Tabletop Movement Failure
Philips Ingenia 3.0T MRI systems may fail to move the patient tabletop completely in or out, potentially delaying patient evacuation and treatment. 266 units are affected worldwide.
Product
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2417-2021·2021-09-15
Philips MRI System Tabletop May Not Fully Move in Manual Mode
Philips Ingenia 3.0T-a MRI systems have an issue where the tabletop may not completely move in or out during manual operation. This could delay patient evacuation from the scanner bore and postpone medical treatment.
Product
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2415-2021·2021-09-15
MRI System Tabletop May Fail to Move, Delaying Patient Evacuation
Philips MRI systems (Model 781260) may have a tabletop malfunction in manual mode that prevents complete movement, potentially delaying patient evacuation and treatment.
Product
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremitie
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2347-2021·2021-09-01
MRI System Pressure Relief Valve Installation Error May Release Helium Gas
Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.
Product
Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Numb
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2345-2021·2021-09-01
MRI System Pressure Valve Installation Error Poses Helium Release Risk
A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.
Product
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2341-2021·2021-09-01
MRI System Pressure Relief Valve Defect May Release Helium Gas
Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.
Product
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2346-2021·2021-09-01
MRI System Pressure Relief Valve Defect May Cause Helium Release
Philips Achieva 3.0T MRI systems may have an incorrectly installed pressure relief valve that could release helium gas and cause injury. Affected units are distributed in the United States and internationally.
Product
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2342-2021·2021-09-01
Philips Ingenia MRI System recalled due to incorrect pressure relief valve
Philips recalled 27 units of the Ingenia 1.5T Magnetic Resonance system with an incorrect pressure relief valve (42 psi instead of 3.75 psi) that could release helium gas and cause injury.
Product
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2021·2021-09-01
Philips Ingenia MRI System Equipped With Incorrect Pressure Relief Valve
Philips Ingenia Elition X MRI systems contain an incorrectly installed pressure relief valve that may release helium gas and cause injury. The recall affects 6 U.S. units and 12 units distributed internationally.
Product
Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Numb
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2343-2021·2021-09-01
Diagnostic MRI system recalled for pressure relief valve defect
A Philips Ingenia MRI system has been recalled due to installation of a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in helium gas release and injury.
Product
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2317-2021·2021-08-25
IQon Spectral CT System Software Error Increases Contrast Volume
Philips IQon Spectral CT systems can recommend excessive contrast volume when patient weight is set to pounds due to a SynchRight software calculation error, potentially resulting in patient overdose.
Product
728332 IQon Spectral CT-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2316-2021·2021-08-25
CT system software error recommends excessive contrast volume
A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.
Product
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2318-2021·2021-08-25
CT X-ray System Software Miscalculates Contrast Volume with Pounds Unit Setting
Philips 728333 Spectral CT 7500 systems with SynchRight software may incorrectly calculate and recommend increased contrast volume when patient weight is set to pounds. Affected system should be updated to prevent excess contrast dosing.
Product
728333 Spectral CT 7500 -Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2315-2021·2021-08-25
CT5000 X-ray System Contrast Dose Calculation Error Under Pounds Setting
Philips CT5000 X-ray systems may incorrectly calculate contrast volume doses when patient weight units are set to pounds. The software error could recommend higher-than-intended contrast volumes.
Product
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2314-2021·2021-08-25
Brilliance iCT Computed Tomography Systems Recalled for Contrast Dosing Error
Philips Brilliance iCT CT systems with SynchRight P3T software may recommend incorrect contrast volume when patient weight is entered in pounds, potentially affecting patient safety.
Product
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1979-2021·2021-07-07
Philips CT Monitor Bracket Assembly risks ceiling fall hazard
Philips is recalling 1,301 Monitor Bracket Assemblies used in CT and PET/CT imaging systems worldwide due to potential shaft wear that could cause the monitor to detach from the ceiling mount and fall, posing injury risk.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1990-2021·2021-07-07
Monitor Bracket Assembly Shaft Wear Risk in Philips CT Fluoroscopy Systems
Philips CT fluoroscopy monitor brackets may detach from suspension arms due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1986-2021·2021-07-07
Philips CT Monitor Bracket Assemblies Recalled for Detachment Risk
Philips has recalled 1,301 Monitor Bracket Assemblies for CT systems worldwide due to shaft wear that could cause monitors to detach and fall, potentially injuring patients, operators, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1980-2021·2021-07-07
Philips Continuous CT Fluoroscopy Monitor Bracket Assembly Fall Risk
Philips is recalling 1,301 Monitor Bracket Assemblies due to shaft wear that could cause the assembly to detach from the ceiling suspension arm. This could result in the monitor falling and causing serious injury to patients, operators, bystanders, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1984-2021·2021-07-07
Philips CT Monitor Bracket Assembly May Detach and Fall
Philips is recalling 1,301 monitor bracket assemblies for CT imaging systems due to shaft wear that could cause detachment and fall of the monitor. This could result in serious injury to patients, operators, and staff.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1988-2021·2021-07-07
Philips Monitor Bracket Assembly falls due to shaft wear in medical imaging systems
Philips monitor bracket assemblies for CT/PET imaging systems may detach due to shaft wear, posing a risk of the monitor falling and causing serious injury to patients, operators, or bystanders.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2021·2021-07-07
Philips Medical Monitor Bracket May Detach from Ceiling Mount
Philips medical imaging monitors with worn bracket assembly shafts may detach from ceiling suspensions and fall on patients, operators, or staff. No injuries have been reported.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1983-2021·2021-07-07
CT Monitor Bracket Assembly Recalled Due to Shaft Wear and Detachment Risk
Philips North America is recalling CT system monitor bracket assemblies due to shaft wear that could cause the bracket to detach from the suspension arm, potentially allowing the monitor to fall and cause serious injury.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1981-2021·2021-07-07
Monitor bracket assembly recalled for detachment hazard on CT imaging systems
Philips is recalling 1,301 monitor bracket assemblies for CT/PET-CT imaging systems due to shaft wear that could cause detachment from the suspension arm, potentially resulting in the monitor falling and serious injury.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brillia
Category
Medical Device
Distribution
Distributed nationwide