Philips Achieva 1.5T MRI Systems Recalled for Gradient Coil Fire Risk
Philips is recalling Achieva 1.5T MRI systems because the gradient coil component could fail and produce smoke or fire. The recall affects 2 units 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 recall for potential gradient coil failure that could produce fire and smoke, with no incidents reported. This meets the rubric for High severity as a risk-of-harm product without reported injury.
Plain-English summary
Philips North America LLC is recalling the Achieva 1.5T Initial System, a magnetic resonance imaging (MRI) machine used in medical facilities. The recall involves 2 units.
A potential failure in the gradient coil—a key component of the MRI system—could result in smoke and/or fire. The affected units have serial numbers 21605 and 21695.
The units have been distributed nationwide in the United States and to numerous countries worldwide, including Canada, United Kingdom, Germany, France, Japan, and Australia.
The recalled product
- Product
- Achieva 1.5T Initial System
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Hazard
- fire
- smoke
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 No. 781178
- UDI-DI: N/A
- Serial No. 21605
- 21695.
Distribution
Distributed nationwide across the United States.
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