Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall
Philips is recalling two Intera 1.5T MRI systems due to a gradient coil component failure that can produce smoke or fire, posing risks of inhalation injury, burns, asphyxia, or death.
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: This is an FDA Class II recall involving a risk-of-harm product (fire, smoke inhalation, burns, asphyxia, and potential death). The source text describes the potential hazard but does not report any illnesses or injuries that have actually occurred, keeping it at the High threshold rather than Severe or Critical.
Plain-English summary
Philips North America is recalling two Intera 1.5T Master/Nova MRI systems (Product Number 781106; Serial Numbers 8009 and 18863) due to an identified component failure in the gradient coil. This failure can act as a heat source and potentially produce smoke and/or fire during operation.
If smoke or fire occurs, patients and operators face risks including inhalation of smoke, burns, asphyxia, and potentially fatal injury. The systems are located in the United States (Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota) and internationally (Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain).
Affected facilities should immediately cease use of the recalled systems and contact Philips North America for instructions on inspection, repair, or replacement. The FDA classified this recall as Class II.
The recalled product
- Product
- Intera 1.5T Master/Nova Product Number: 781106;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke-inhalation
- burn-injury
- 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 (4)
- Product Number: 781106
- UDI-DI: no UDI
- Serial Numbers: 8009
- 18863
Distribution
Distributed nationwide across the United States.
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