The Recall Desk
HighFDA (Devices)·Z-1854-2024·Announced 2024-05-29

Philips MR 5300 magnetic resonance systems' mains distribution unit may ignite

Philips has recalled 81 MR 5300 MRI systems worldwide due to a loose electrical connection that may overheat and cause fire or smoke 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: This is an FDA Class II recall involving a potential fire and smoke hazard in medical equipment. No illnesses, injuries, or property damage have been reported, making this a theoretical risk-of-harm scenario rather than one with confirmed incidents.

Plain-English summary

Philips North America is recalling 81 MR 5300 magnetic resonance (MR) systems distributed worldwide, including throughout the United States and multiple international locations. These systems are used for diagnostic medical imaging.

The recalled systems have a global Mains Distribution Unit (g-MDU) L3 with a terminal connection that may become loose. When loose, this connection can create a hotspot that may generate smoke and fire, potentially in the hospital's technical room where the equipment is located.

No illnesses, injuries, or property damage have been reported to date. Affected facilities using these systems should contact Philips for guidance on inspection and remediation of their equipment.

The recalled product

Product
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
Manufacturer
Philips North America Llc
Hazard
  • fire
  • smoke

Distribution

Distributed nationwide across the United States.