MRI System Gradient Coil Component Failure Poses Fire and Smoke Risk
Philips Intera 1.5T MRI systems may experience gradient coil component failure that can produce smoke or fire, posing risks of burns, inhalation injury, and asphyxia to patients and operators.
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, potential thermal and inhalation injuries) where no injuries or deaths have been reported yet. Per the rubric, risk-of-harm recalls without reported injury are classified as High (score 3).
Plain-English summary
Philips North America is recalling the Intera 1.5T Omni/Stellar MRI system (Product Number 781104) due to a potential component failure in the gradient coil.
A failure in the gradient coil component can act as a heat source and potentially produce smoke or fire. If this occurs, patients and operators face risks including inhalation of smoke, burns, and asphyxia, which may lead to serious injury or death. The incident could also cause property damage.
This recall affects two units distributed worldwide to the following locations: Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain, and the US states of Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota. The affected systems have serial numbers 10403 and 18969.
Philips has issued this Class II recall to address the identified safety hazard. Facilities and operators with affected systems should contact Philips North America for guidance on remediation and further instructions.
The recalled product
- Product
- Intera 1.5T Omni/Stellar; Product Number: 781104;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke
- burn-injury
- inhalation-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: 781104
- UDI-DI: no UDI
- Serial Numbers: 10403
- 18969
Distribution
Distributed nationwide across the United States.
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