Philips 1.5T MRI System Gradient Coil May Overheat and Produce Smoke or Fire
Philips is recalling Intera 1.5T MRI systems because a Gradient Coil component failure can cause the system to overheat and produce smoke or fire, risking inhalation injury, 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: This is a Class II FDA recall involving a risk-of-harm medical device with potential for serious injury or death (asphyxia, burns, smoke inhalation), but no illnesses or injuries have been reported. Per the severity rubric, this qualifies as High (Score 3) because it represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America is recalling Intera 1.5T Achieva Nova-Dual MRI systems (Product Number 781173) due to a critical safety issue. The recall affects 3 units: 1 in the United States and 2 outside the United States. US-located units are distributed across Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota. International units are located in Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain. Affected serial numbers are 13010, 13006, and 21501.
The issue involves a component failure in the Gradient Coil that can act as a heat source and potentially produce smoke and/or fire during system operation. This defect creates a significant safety risk to patients and operators.
If smoke or fire occurs, individuals in proximity to the affected MRI system may experience inhalation of smoke, burns, and/or asphyxia, which may lead to serious injury or death. The malfunction also poses a risk of property damage.
Philips recommends that healthcare facilities and operators cease use of affected systems immediately and contact Philips for guidance on remediation or replacement.
The recalled product
- Product
- Intera 1.5T Achieva Nova-Dual Product Number: 781173;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- 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 (5)
- Product Number: 781173
- UDI-DI: no UDI
- Serial Numbers: 13010
- 13006
- 21501
Distribution
Distributed nationwide across the United States.
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