Philips MR 5300 MRI Systems Gradient Coil Fire and Smoke Risk
Philips is recalling certain MR 5300 magnetic resonance imaging systems due to potential gradient coil component failures that could generate heat, smoke, or fire. The recall affects 551 units distributed worldwide, including the United States.
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 with risk of fire and smoke from gradient coil component failure. No injuries, deaths, or illnesses have been reported. This meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America is recalling certain MR 5300 magnetic resonance imaging (MRI) systems due to a potential component failure in the gradient coil. Affected systems have model numbers 782110, 782135, or 782152, with specific serial numbers listed by Philips.
The gradient coil component in affected units may experience failures that could act as a heat source, potentially producing smoke and/or fire during normal operation. This represents a fire and smoke hazard to facilities operating these systems.
Approximately 551 units were distributed worldwide, including throughout the United States and to multiple countries globally.
Facilities using affected MR 5300 systems should cease operation of the device and contact Philips North America for guidance on repair, replacement, or other remedial actions.
The recalled product
- Product
- MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke
- heat-source
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) 782110
- (2) 782135
- (3) 782152
- UDI-DI: (1) 00884838099364
- (2) None
- (3) 00884838112841
- Serial Numbers: (1) 63000
- 63001
- 63006
- 63007
- 63008
- 63009
- 63010
- 63011
- 63012
- 63013
- 63014
- 63015
- 63016
- 63018
Distribution
Distributed nationwide across the United States.
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