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.
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 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
- Affected units
- 81
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.
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