Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall
Philips is recalling two Intera 1.5T Master/Nova MRI systems due to a potential gradient coil component failure that could overheat and produce smoke or fire, risking inhalation injuries, 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 medical device recall with potential for serious hazard (fire, smoke production, thermal injury risk) but no reported illnesses or injuries. Scores 3 (High) per rubric: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America is recalling Intera 1.5T Master/Nova MRI systems (Product Number 781106) due to a potential safety issue with the gradient coil component.
A component failure in the gradient coil type of these systems can potentially act as a heat source and produce smoke and/or fire. If smoke or fire occurs during patient imaging or operation, the risks to patients and medical staff include inhalation of smoke, burns, and asphyxiation, which may lead to serious injury or even death. Additionally, the fire could cause property damage.
Two units have been identified as affected. Individuals with access to these systems should contact Philips North America for guidance on addressing this safety issue.
The recalled product
- Product
- Intera 1.5T Master/Nova Product Number: 781106;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- Hazard
- fire
- smoke-inhalation
- burn-injury
- component-failure
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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