Agency classClass IIOur severity:High FDA (Devices)·Z-1845-2024·Announced 2024-05-29

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Diagnostic Imaging / MRI
Hazard: fire
smoke
electrical-hazard
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.

See all 30 products in this recall →

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Same hazard · fire