Manufacturer

Philips North America Llc

302 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.

251–275 of 302

HighFDA (Devices)·Z-0281-2022·2021-12-01
Continuous CT Fluoroscopy Ceiling Mount Bracket Assembly Wear Recall
Monitor bracket assemblies in Philips Continuous CT Fluoroscopy systems may experience significant wear and detach, potentially injuring patients, operators, or bystanders during surgical procedures.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0279-2022·2021-12-01
PET/CT Imaging System Ceiling Mount May Detach Due to Bracket Wear
Philips TruFlight Select PET/CT imaging systems have a Monitor Bracket Assembly that may detach from the ceiling mount due to undetected shaft wear, posing a risk of injury to patients, staff, and bystanders.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0277-2022·2021-12-01
CT imaging system ceiling mount bracket shaft wear may cause equipment to fall
A CT fluoroscopy imaging system ceiling mount's bracket shaft may wear excessively and go undetected, potentially causing the bracket to detach and fall, risking injury to patients, operators, or service personnel.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0280-2022·2021-12-01
Philips CT Fluoroscopy Ceiling Mount Bracket Wear and Detachment Hazard
Philips Continuous CT Fluoroscopy ceiling mounts may experience monitor bracket assembly wear that goes undetected, potentially causing the bracket to detach and fall on patients, operators, or bystanders during surgery.
Product
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0213-2022·2021-11-17
Philips Azurion X-Ray Systems may lock up during simultaneous button presses
Philips Azurion Interventional X-Ray Systems (software 2.1.x) may experience imaging lock-up when operators simultaneously press both the APC and Float Tabletop buttons.
Product
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0079-2022·2021-10-20
Philips Defibrillators Recall: Customers Uninformed of Previous Recalls
Customers of Philips HeartStart FRx defibrillators were not notified of previous recalls associated with various defibrillator models. This is a Class II medical device recall.
Product
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0078-2022·2021-10-20
Philips HeartStart Defibrillator Recall: Previous Recall Notifications Not Sent
Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.
Product
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0081-2022·2021-10-20
Philips HeartStart HS1 OnSite Defibrillator Recall: Notification of Previous Recalls
Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.
Product
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0080-2022·2021-10-20
Philips HeartStart HS1 Home Defibrillator: Customers Not Notified of Previous Recalls
Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.
Product
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2475-2021·2021-09-22
Philips Allura Xper Imaging System Overheating and Malfunction Recall
Philips Allura Xper imaging systems may fail early when supplied with 480V, causing coil overheating and burning smell. When the system fails, X-ray imaging capability is reduced to emergency mode only.
Product
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2476-2021·2021-09-22
Philips Azurion Imaging System Failure at 480V Hospital Power Supply
Philips Azurion medical imaging devices may fail when powered by hospital electrical systems providing 480V. The failure reduces X-ray performance and may be preceded by a burning smell.
Product
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2474-2021·2021-09-22
Philips Allura Xper X-ray imaging system failures at 480V power supply
Four Philips Allura Xper X-ray imaging systems may fail prematurely when powered at 480V hospital mains, causing coil overheating and reduced imaging performance.
Product
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2422-2021·2021-09-15
Philips Ingenia Ambition X MRI System Tabletop May Fail to Retract
Philips Ingenia Ambition X MRI systems may have tabletops that fail to move completely in manual mode, potentially delaying patient evacuation from the scanner and treatment. The issue affects 147 units distributed worldwide.
Product
Ingenia Ambition 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 Models:
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
HighFDA (Devices)·Z-2412-2021·2021-09-15
Philips Ingenia 1.5T MRI tabletop malfunction may delay patient evacuation
Philips is recalling 42 Ingenia 1.5T MRI systems because the tabletop may not fully move in or out in manual mode, potentially delaying patient evacuation and treatment.
Product
Ingenia 1.5T Evolution-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 Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2427-2021·2021-09-15
Philips HEARTSTART Infant/Child Defibrillator Pads Recalled for Incorrect Labeling
Philips infant/child defibrillator pads are recalled due to incorrect labeling that could delay therapy or result in lower energy delivery than indicated.
Product
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2419-2021·2021-09-15
MRI Tabletop May Not Move Properly in Manual Mode
The patient tabletop on affected Philips Ingenia Elition MRI systems may not move completely in or out during manual operation, potentially delaying patient evacuation from the device.
Product
Ingenia Elition X-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-2413-2021·2021-09-15
MRI device tabletop may fail to move completely in manual mode
Philips Ingenia MRI tabletops may fail to move completely in manual mode, potentially delaying patient evacuation. The recall affects 144 units worldwide.
Product
Ingenia 1.5T S-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 Model: 7813
Category
Medical Device
Distribution
Distributed nationwide
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-2416-2021·2021-09-15
Ingenia Ambition S-a MRI System tabletop may not move in manual mode
The Philips Ingenia Ambition S-a MRI system may not fully move its patient tabletop in or out of the bore during manual mode operation, potentially delaying patient evacuation and treatment.
Product
Ingenia Ambition S-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-2421-2021·2021-09-15
MRI Tabletop Movement Failure May Delay Patient Evacuation and Treatment
Philips MRI systems may fail to move the examination tabletop in manual mode, potentially delaying patient evacuation and medical treatment.
Product
SmartPath to dStream for XR and 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 ext
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2411-2021·2021-09-15
MRI diagnostic device tabletop may not move completely in manual mode
Philips Ingenia 1.5T MRI systems may have a mechanical defect where the tabletop fails to move fully in and out during manual operation, potentially delaying patient evacuation and treatment.
Product
Ingenia 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 extremities Models: 781
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2418-2021·2021-09-15
MRI Magnetic Resonance System Tabletop May Fail to Move in Manual Mode
Philips Ingenia Elition S-a MRI systems may have tabletop movement failure in manual mode, potentially delaying patient evacuation from the scanner bore and treatment. This affects 64 units distributed worldwide.
Product
Ingenia Elition S-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
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