SmartPath to Ingenia Elition X gradient coils may overheat
SmartPath to Ingenia Elition X systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 33 units affected.
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: Risk-of-harm product: a component that may produce smoke or fire in a scanner enclosing a patient, with no injury reported in the source.
Plain-English summary
SmartPath to Ingenia Elition X, model numbers 782118 and 782144, UDI-DI 00884838099746 and 00884838108677, is being recalled. The action covers 33 units, identified by the serial numbers in the recall notice.
The stated reason is the potential for component failures in the gradient coil of the affected MR systems, which may act as a heat source with a potential to produce smoke and/or fire. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States and to Albania, Algeria and Angola among other markets. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the model numbers, UDI-DI codes and serial numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI system
- Hazard
- gradient-coil
- overheating
- fire-hazard
- smoke
- class-ii
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) 782118
- (2) 782144
- UDI-DI: (1) 00884838099746
- (2) 00884838108677
- Serial Numbers: (1) 42049
- 42054
- 42072
- 42085
- 42098
- 42113
- 42158
- 42159
- 42160
- 42167
- 42194
- 42301
- 42306
- 42329
- 42340
- 71019
Distribution
Distributed nationwide across the United States.
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