Philips North America
45 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Philips North America and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-08-06FDA-DeviceClass IIIngenia 1.5T S Model Number (REF): 781347;
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.
- 2025-08-06FDA-DeviceClass IIIngenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
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.
- 2025-08-06FDA-DeviceClass IIEvolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;
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.
- 2025-08-06FDA-DeviceClass IIEvolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
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.
- 2025-08-06FDA-DeviceClass IIAchieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
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.
- 2025-08-06FDA-DeviceClass IIAchieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
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.
- 2025-06-18FDA-DeviceClass IISmartPath to dStream for 1.5T¿; Product Number: 782146;
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.
- 2025-06-18FDA-DeviceClass IIIntera Achieva 1.5T Pulsar; Product Number: 781171;
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.
- 2025-06-18FDA-DeviceClass IIIntera 1.5T Omni/Stellar; Product Number: 781104;
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.
- 2025-06-18FDA-DeviceClass IIIntera 1.5T Master/Nova Product Number: 781106;
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.
- 2025-06-18FDA-DeviceClass IIIntera 1.5T Explorer/Nova Dual Product Number: 781108;
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.
- 2025-06-18FDA-DeviceClass IIIntera 1.5T Achieva Nova-Dual Product Number: 781173;
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.
- 2025-06-18FDA-DeviceClass IIIntera 1.5T Achieva Nova Product Number: 781172;
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.
- 2025-06-18FDA-DeviceClass IIIntera 1.5T Achieva IT Nova Product Number: 781175
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.
- 2025-06-18FDA-DeviceClass IIAchieva XR Product Numbers: (1) 781153, (2) 781253;
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.
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