Agency classClass IIOur severity:High FDA (Devices)·Z-1849-2024·Announced 2024-05-29

MRI Scanner Terminal Connection Fire and Smoke Risk

Philips Ingenia 3.0T CX MRI scanners may experience loose terminal connections in the global Mains Distribution Unit (g-MDU) that could create fire or smoke hazards. The recall affects 350 units distributed worldwide.

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: FDA Class II recall for a fire and smoke hazard in medical equipment where no injuries or property damage have been reported. This represents a risk-of-harm scenario with electrical fire potential, but lacks documented harm to justify a higher severity score.

Plain-English summary

Philips has recalled the Ingenia 3.0T CX MRI scanner (model numbers 782105 and 781271) due to a potential electrical hazard in the global Mains Distribution Unit (g-MDU). The L3 terminal connection in this component may become loose over time.

A loose terminal connection creates a hotspot that could cause smoke or fire to develop in the hospital's technical room where the MRI equipment is housed. This poses a fire hazard to the facility and its occupants.

The recall affects approximately 350 units that have been distributed worldwide, including locations in the United States and 26 other countries including Canada, France, Germany, Japan, the United Kingdom, and others.

Hospitals and medical facilities with affected Ingenia 3.0T CX MRI scanners should contact Philips North America LLC for instructions on how to address this issue. Do not operate the equipment if you suspect a loose terminal connection.

The recalled product

Product: Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / MRI Scanner
Hazard: fire
electrical-hazard
smoke
Affected units: 350

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 (1)

UDI-DI: (1) (01)00884838098312(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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