Philips MRI Systems Recalled for Gradient Coil Fire and Smoke Hazard
Philips North America is recalling 136 Ingenia MRI systems due to potential gradient coil failures that could generate heat and produce smoke or fire. The affected units have been 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 FDA Class II recall involves a potential fire and smoke hazard from gradient coil component failures. Although no illnesses or injuries have been reported, the potential for these systems to produce smoke and fire represents a significant risk-of-harm in medical settings, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America is recalling Ingenia 1.5T S MRI systems (Model Number 781347) due to potential component failures in the gradient coil. A total of 136 units are affected.
Component failures in the gradient coil may act as a heat source with potential to produce smoke and/or fire. This presents a fire and smoke hazard.
The affected units have been distributed worldwide, including throughout the United States and to numerous countries.
The recalled product
- Product
- Ingenia 1.5T S Model Number (REF): 781347;
- Manufacturer
- Philips North America
- 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 Number (REF): 781347
- UDI-DI: 00884838068421
- Serial Numbers: 81001
- 81003
- 81004
- 81005
- 81006
- 81007
- 81008
- 81009
- 81010
- 81011
- 81013
- 81014
- 81015
- 81016
- 81017
- 81018
- 81019
- 81020
Distribution
Distributed nationwide across the United States.
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