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.

51–75 of 302

HighFDA (Devices)·Z-1791-2025·2025-05-28
Imaging device alignment error in cross-reference line functionality
Philips' SmartPath to Ingenia Elition X imaging devices (model numbers 782118 and 782144) may experience alignment errors in the cross-reference line when reviewing images with the MobiView application. Sixteen units have been distributed worldwide.
Product
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1793-2025·2025-05-28
Philips Evolution Upgrade 1.5T medical imaging device recalled for alignment errors
Philips is recalling Evolution Upgrade 1.5T imaging devices due to potential alignment errors in the MobiView application's cross-reference line functionality. Misalignment could lead to inaccurate diagnostic positioning information.
Product
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1800-2025·2025-05-28
Ingenia 3.0T CX MRI alignment error in MobiView image analysis
Philips recalls the Ingenia 3.0T CX MRI system due to potential alignment errors in the MobiView application's cross reference line function. The 37 affected units are located outside the United States.
Product
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1795-2025·2025-05-28
Ingenia 1.5T MRI system alignment errors in image review
Philips Ingenia 1.5T MRI systems may display alignment errors in the cross-reference line when reviewing images with the MobiView application, potentially affecting image interpretation.
Product
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1804-2025·2025-05-28
Philips MR 5300 Imaging System Alignment Error Recall Worldwide
Philips has recalled the MR 5300 medical imaging system due to potential alignment errors in the cross reference line functionality. These errors could affect image accuracy when reviewing images with the MobiView application.
Product
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1801-2025·2025-05-28
Philips Ingenia Ambition X MRI System Alignment Error in Image Review
Philips is recalling 300 Ingenia Ambition X MRI systems due to potential alignment errors in the cross-reference line functionality when reviewing images with the MobiView application. This error could affect diagnostic accuracy.
Product
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1805-2025·2025-05-28
MR 7700 Medical Imaging Device: Alignment Error in Cross Reference Review
Philips MR 7700 medical imaging devices may have alignment errors when reviewing cross reference lines in images generated with the MobiView application. This could affect diagnostic accuracy.
Product
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1792-2025·2025-05-28
Philips MR 7700 upgrade recalled for image alignment errors
Philips recalls upgrade to MR 7700 system due to potential alignment errors in MobiView cross-reference line functionality when reviewing images. No injuries or illnesses reported.
Product
Product Name: Upgrade to MR 7700; Model Number: 782130;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1722-2025·2025-05-14
Philips neonatal and adult CO2 filter line adapter may not disconnect
Philips neonatal and adult CO2 filter lines may have adapters that are difficult or impossible to disconnect from endotracheal tubes. This Class II recall affects approximately 486,631 units distributed worldwide.
Product
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm ,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1582-2025·2025-04-30
Philips Veradius Unity Foot Switch May Emit Unintended Radiation
Philips is recalling Veradius Unity radiological devices because the wireless foot switch may stick in the active position, causing unintended radiation emission during medical procedures.
Product
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1580-2025·2025-04-30
Philips Zenition 50 Wireless Foot Switch May Get Stuck, Emit Unintended Radiation
Philips is recalling Zenition 50 radiological devices because the wireless foot switch pedal may get stuck in active position, potentially causing unintended radiation emission during medical procedures.
Product
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1581-2025·2025-04-30
Zenition 70 Radiological Device Wireless Foot Switch Unintended Radiation Recall
Philips Zenition 70 radiological imaging devices are recalled because their wireless foot switch pedal may become stuck in the active position when released, resulting in unintended radiation emission during diagnostic and surgical procedures.
Product
Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1660-2025·2025-04-30
Philips Brilliance CT Scanner Unintended Gantry Motion Poses Collision Risk
Philips is recalling 630 Brilliance CT Big Bore systems due to unintended motion in the interventional control that may cause the gantry or table to collide with operators or patients.
Product
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1554-2025·2025-04-23
X-Ray System Collimator Fall Risk Due to Incorrect Installation
Philips DXR System X-ray units may have a collimator that could fall if installed incorrectly. Healthcare facilities should verify proper installation of affected units.
Product
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1553-2025·2025-04-23
Philips DXR stationary X-ray system recalled due to collimator installation defect
Philips is recalling 83 DXR X-ray systems worldwide due to a potential installation defect that could cause the collimator to fall during operation.
Product
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1109-2025·2025-02-12
IntelliVue Patient Monitor MX500 may fail to generate critical alarms
Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.
Product
IntelliVue Patient Monitor MX500. Model Number: 866064
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1106-2025·2025-02-12
IntelliBridge EC10 Module may fail to alarm on ventilator disconnection
The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.
Product
IntelliBridge EC10 Module. Model Number: 865115
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1107-2025·2025-02-12
Patient Monitor May Fail to Alarm on Ventilator Disconnect
Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.
Product
IntelliVue Patient Monitor MX400. Model Number: 866060
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1110-2025·2025-02-12
IntelliVue Patient Monitor MX550 May Fail to Alarm on Ventilator Disconnection
Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.
Product
IntelliVue Patient Monitor MX550. Model Number: 866066
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1108-2025·2025-02-12
Patient Monitor May Fail to Alert When Ventilator Disconnects
Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.
Product
IntelliVue Patient Monitor MX450. Model Number: 866062
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0686-2025·2024-12-25
Philips Access Point Software Issue Risks Patient Data Loss
Philips Smart-Hopping 2.0 Access Points may reset after 82 days, risking loss of patient data and network disconnections. No injuries have been reported.
Product
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2025·2024-12-11
Spectral CT Devices Pose Collision and Misdiagnosis Software Risks
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2025·2024-12-04
Mammotrak Interventional Coil 1.5T recalled for patient safety risk
Philips is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T nationwide due to a potential safety issue that may harm patients during MRI preparation or scanning.
Product
Mammotrak Interventional Coil 1.5T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2025·2024-12-04
Philips ST SENSE Breast Coil Recalled for Potential Patient Safety Risk
Philips is recalling 5,231 ST SENSE Breast Coils nationwide due to a potential safety issue that could harm patients during MRI scanning. Affected units are identified by specific serial numbers.
Product
ST SENSE Breast Coil
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0539-2025·2024-12-04
Philips Breast MRI System Recalled for Patient Safety Risk
Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.
Product
dS Breast 7ch 1.5T
Category
Medical Device
Distribution
Distributed nationwide