Achieva 3.0T MRI Systems Recalled Due to Gradient Coil Fire Risk
Philips North America is recalling Achieva 3.0T MRI systems due to potential gradient coil component failures that could produce smoke or fire. The recall affects 460 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: This is an FDA Class II recall for a medical device with a documented fire and smoke hazard from potential gradient coil component failures. Although no incidents or injuries have been reported, the hazard presents genuine risk of harm in clinical environments, meeting the threshold for a risk-of-harm product without reported injury.
Plain-English summary
Philips North America is recalling certain Achieva 3.0T MRI systems (models 781177, 781277, 781278, 781344, and 781345). A total of 460 units have been distributed worldwide, with distribution spanning the United States and numerous other countries.
The affected systems have the potential for component failures in the gradient coil that could act as a heat source, potentially resulting in smoke and/or fire.
The FDA has classified this as a Class II recall. For additional information and instructions, consult the official FDA recall notice or contact Philips North America directly.
The recalled product
- Product
- Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
- Manufacturer
- Philips North America
- 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 (20)
- Model Numbers (REF): (1) 781177
- (2) 781277
- (3) 781278
- (4) 781344
- (5) 781345
- UDI-DI: (1) None
- (2) None
- (3) 00884838004139
- (4) None
- (5) None
- Serial Numbers: (1) 17008
- 17011
- 17017
- 17030
- 17035
- 17038
- 17039
- 17043
- 17049
- 17051
Distribution
Distributed nationwide across the United States.
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