Philips North America

46 FDA enforcement actions

46 Total Recalls

0 Class I

46 Class II

0 Class III

Firm Details

Product Types: device
States: MA

All Recalls

Class II: Risk 12/22/2025 device

A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025 device

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 10/27/2025 device

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
Class II: Risk 09/12/2025 device

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Class II: Risk 09/12/2025 device

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 06/30/2025 device

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 05/29/2025 device

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Class II: Risk 08/30/2024 device

During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.