MRI Machine Gradient Coil Potential Failure Could Produce Smoke and Fire
Philips Ingenia 1.5T CX MRI systems may experience gradient coil failure that could produce smoke and/or fire. The FDA has classified this as a Class II recall affecting 48 units distributed nationwide and internationally.
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 involving medical diagnostic equipment with potential fire and smoke hazard from component failure. No illnesses or injuries have been reported; the hazard remains theoretical. This risk-of-harm scenario warrants a High severity classification.
Plain-English summary
Philips North America LLC is recalling the Ingenia 1.5T CX magnetic resonance imaging (MRI) system due to a potential component failure. The gradient coil in affected units may fail, producing smoke and/or fire.
The recall affects 48 units of this diagnostic imaging equipment classified as FDA Class II. The systems have been distributed nationwide in the United States and to facilities in more than 40 countries worldwide.
Facilities operating affected systems should verify if their equipment matches the recalled product numbers and serial numbers listed in the FDA's official recall notice. Healthcare providers should contact Philips North America LLC with questions or to discuss potential mitigation measures.
The recalled product
- Product
- Ingenia 1.5T CX
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- smoke
- equipment-failure
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)
- Product No. 781261 & 781262
- UDI-DI: (01)00884838068438(21)77008
- (01)00884838068438(21)77016
- (01)00884838068438(21)77018
- (01)00884838068445(21)77032
- (01)00884838068445(21)77034
- (01)00884838068445(21)77035
- (01)00884838068445(21)77038
- (01)00884838068445(21)77040
- (01)00884838068445(21)77041
- (01)00884838068445(21)77046
- (01)00884838068445(21)77049
- (01)00884838068445(21)77050
- (01)00884838068445(21)77054
- (01)00884838068445(21)77056
- (01)00884838068445(21)77058
- (01)00884838068445(21)77059
- (01)00884838068445(21)77061
- (01)00884838068445(21)77062
- (01)00884838068445(21)77065
Distribution
Distributed nationwide across the United States.
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