Philips Achieva XR MRI Systems Recalled Due to Gradient Coil Fire Hazard
Philips is recalling Achieva XR MRI systems due to a gradient coil component defect that can generate heat, potentially producing smoke or fire. Patients and operators face risks of inhalation injury, thermal burns, and asphyxia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for an identified component defect capable of producing fire and smoke with potential for serious injury or death, including asphyxia. No illnesses or injuries have been reported. This meets the rubric criterion for score 3: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America is recalling Achieva XR MRI systems (Product Numbers 781153 and 781253) due to an identified issue where a gradient coil component failure can act as a heat source, potentially producing smoke and/or fire.
When smoke or fire occurs, patients and operators may be exposed to inhalation of smoke, thermal burns, and/or asphyxia, which may lead to injury or even death. The defect also poses a risk of property damage.
Six units have been distributed: five within the United States and one outside the US. Within the US, affected systems are located in Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota. Internationally, affected systems are located in Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain. All serial numbers of the recalled product numbers are included in this recall.
Users of these systems should immediately discontinue use and contact Philips North America for instructions on correction or replacement.
The recalled product
- Product
- Achieva XR Product Numbers: (1) 781153, (2) 781253;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- Hazard
- fire
- smoke-inhalation
- thermal-burn
- asphyxia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product Numbers: (1) 781153
- (2) 781253
- UDI-DI: (1) no UDI
- (2) no UDI
- Serial Numbers: All serial numbers
Distribution
Distributed nationwide across the United States.
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