The Recall Desk
HighFDA (Devices)·Z-1846-2024·Announced 2024-05-29

Philips Ingenia MR Systems Recalled for Fire Risk From Loose Connector

Philips is recalling Ingenia 1.5T CX Magnetic Resonance systems due to a loose power distribution connection that may create a fire hazard in hospital technical rooms.

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: FDA Class II medical device with potential fire and smoke hazard. Qualifies as a risk-of-harm product where no injuries have been reported, placing it in the High severity category.

Plain-English summary

Philips North America LLC is recalling Ingenia 1.5T CX Magnetic Resonance (MR) systems with model numbers 781262 and 781261. These are diagnostic imaging devices used in hospitals and medical facilities.

The recalled systems contain a global Mains Distribution Unit (g-MDU) L3 that may have a loose terminal connection. This loose connection can create a hotspot that poses a risk of smoke or fire in the hospital's technical room where the equipment is installed.

Systems affected by this recall have been distributed worldwide, including throughout the United States and in numerous countries. Healthcare facilities operating these systems should contact Philips for instructions on inspection and remediation.

The recalled product

Product
Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
Manufacturer
Philips North America Llc
Hazard
  • fire
  • smoke
  • electrical-hazard

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) 781262 (01)00884838068445(21)

Distribution

Distributed nationwide across the United States.