Philips MRI Machine Intera 3.0T Quasar Dual Recalled for Fire Risk
Philips is recalling its Intera 3.0T Quasar Dual MRI system due to a potential fire hazard from gradient coil failures. The recall affects one unit distributed worldwide.
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 involving potential fire hazard without reported injuries or illnesses. Per rubric, risk-of-harm products where injury has not yet been reported = High (3).
Plain-English summary
Philips North America is recalling one unit of the Intera 3.0T Quasar Dual MRI system (Model Number REF: 781150). The potential for component failures in the Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. This recall affects the specific unit with serial number 17123 and is distributed worldwide, including throughout the United States and numerous international countries. Consumers should stop using the device immediately and contact Philips North America for instructions on returning the product.
The recalled product
- Product
- Intera 3.0T Quasar Dual Model Number (REF): 781150;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Machine
- Hazard
- fire
- smoke
- 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 (2)
- Model Number (REF): 781150
- UDI-DI: None Serial Numbers: 17123
Distribution
Distributed nationwide across the United States.
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