Philips Ingenia 1.5T MRI machines recalled for loose power connection fire risk
Philips is recalling 2,262 Ingenia 1.5T MRI systems worldwide because a loose terminal connection in the power distribution unit can overheat and cause fire or smoke.
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 a risk-of-harm product with potential for fire and smoke in a hospital technical environment. The source does not report any incidents or injuries. Per the rubric, this qualifies as High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 2,262 Ingenia 1.5T magnetic resonance imaging (MRI) machines due to a defective global Mains Distribution Unit (g-MDU) L3 terminal connection. The affected machines are distributed worldwide, including the United States and multiple other countries.
The terminal connection may become loose, creating a hotspot that could cause smoke and/or fire in the hospital's technical room. This affects six model numbers: 782140, 782115, 782101, 781396, 781341, and 781315.
Hospitals with affected MRI systems should contact Philips for repair or correction guidance. The FDA classified this as a Class II recall.
The recalled product
- Product
- Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
- Manufacturer
- Philips North America Llc
- Affected units
- 2,262
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 (6)
- UDI-DI: (1) 782140 (01)00884838108646(21)
- (2) 782115 (01)00884838099043(21)
- (3) 782101 (01)00884838098275(21)
- (4) 781396 (01)00884838009820(21)
- (5) 781341 (01)00884838055322(21)
- (6) 781315 (01)00884838099715(21)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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