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Philips North America Recalls
530 recalls on record · April 5, 2017 to July 1, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 16, 2023Medical DevicesFDA
Philips North America recalls MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Hazard: During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
August 16, 2023Medical DevicesFDA
Philips North America recalls Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Hazard: During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
August 16, 2023Medical DevicesFDA
Philips North America recalls Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti
Hazard: During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
August 16, 2023Medical DevicesFDA
Philips North America recalls MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Hazard: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
August 16, 2023Medical DevicesFDA
Philips North America recalls Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Hazard: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
August 16, 2023Medical DevicesFDA
Philips North America recalls Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Eliti
Hazard: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
August 9, 2023Medical DevicesFDA
Philips North America recalls Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
Hazard: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
August 9, 2023Medical DevicesFDA
Philips North America recalls Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Hazard: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
August 9, 2023Medical DevicesFDA
Philips North America recalls Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Hazard: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
August 9, 2023Medical DevicesFDA
Philips North America recalls Incisive CT-Computed Tomography X-Ray System Model: 728143
Hazard: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
July 5, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90, Model No. 712034 and 712035
Hazard: There is a software login in issue that may prevent the user from logging in.
June 7, 2023Medical DevicesFDA
Philips North America Llc recalls EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380
Hazard: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
June 7, 2023Medical DevicesFDA
Philips North America Llc recalls EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Hazard: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
May 24, 2023Medical DevicesFDA
Philips North America recalls CombiDiagnost R90 R1.1
Hazard: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
May 24, 2023Medical DevicesFDA
Philips North America recalls CombiDiagnost R90 R.1.0
Hazard: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
May 24, 2023Medical DevicesFDA
Philips North America recalls ProxiDiagnost N90 R.1.0
Hazard: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
May 24, 2023Medical DevicesFDA
Philips North America recalls Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Hazard: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
May 24, 2023Medical DevicesFDA
Philips North America recalls Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
Hazard: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
May 24, 2023Medical DevicesFDA
Philips North America Llc recalls Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Hazard: Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.
May 10, 2023Medical DevicesFDA
Philips North America Llc recalls Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radio
Hazard: Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking
April 19, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Hazard: If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
April 19, 2023Medical DevicesFDA
Philips North America Llc recalls Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Hazard: If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
April 19, 2023Medical DevicesFDA
Philips North America Llc recalls ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
Hazard: If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
April 19, 2023Medical DevicesFDA
Philips North America Llc recalls CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Hazard: If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
January 18, 2023Medical DevicesFDA
Philips North America Llc recalls Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 9898031376
Hazard: Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
December 14, 2022Medical DevicesFDA
Philips North America Llc recalls Philips Upgrade to MR 7700 System, Model Number 782130
Hazard: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
December 14, 2022Medical DevicesFDA
Philips North America Llc recalls Philips MR 7700 System, Model Number 782120
Hazard: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
December 14, 2022Medical DevicesFDA
Philips North America Llc recalls Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Hazard: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
December 14, 2022Medical DevicesFDA
Philips North America Llc recalls Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Hazard: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
December 14, 2022Medical DevicesFDA
Philips North America Llc recalls Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Hazard: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.