Agency classClass IIOur severity:High FDA (Devices)·Z-1848-2024·Announced 2024-05-29

Philips Recalls Ingenia 3.0T MR Systems for Loose Mains Terminal Fire Hazard

Philips is recalling 1,517 Ingenia 3.0T magnetic resonance (MR) systems due to a potentially loose terminal connection in the mains distribution unit that may create a hotspot 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 recall involves FDA Class II medical devices with a potential fire and electrical hazard. No illnesses or injuries have been reported; the hazard is theoretical, placing this at High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 1,517 units of Ingenia 3.0T magnetic resonance (MR) systems, which are diagnostic imaging devices indicated for medical use in hospitals and diagnostic centers.

The recall is due to a potential safety hazard with the global Mains Distribution Unit (g-MDU) L3 terminal connection. This connection may become loose, creating a hotspot that may cause smoke or fire, potentially triggering alarms in the hospital's technical room.

The affected systems have been distributed worldwide, including throughout the United States and to Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. A detailed list of affected units is available from the FDA by serial number.

Healthcare facilities with affected systems should review the FDA recall notice and contact Philips North America LLC for further guidance on remediation measures.

The recalled product

Product: Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging
Hazard: fire
electrical-hazard
smoke
Affected units: 1,517

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 (2)

UDI-DI: (1) 782103 (01)00884838098299(21)
(2) 781377 (01)00884838009813(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 →

Same manufacturer · Philips North America Llc

See all →

High
Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
Moderate
Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
Moderate
Philips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
Moderate
Philips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Moderate
Philips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30

Same hazard · fire