Philips Intera 1.5T MRI System Mains Connection Defect Poses Fire Risk
Philips is recalling 200 Intera 1.5T MRI systems worldwide due to loose mains distribution unit connections that may cause electrical hotspots, creating fire and smoke hazards 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 recall involves an FDA Class II device with a specific electrical hazard creating fire and smoke risk in hospital settings. No injuries have been reported, but the tangible hazard of loose electrical connections warrants High severity classification.
Plain-English summary
Philips North America LLC is recalling approximately 200 Intera 1.5T Magnetic Resonance (MR) diagnostic imaging systems, Model 781295. These systems have been distributed worldwide, including across the United States and 27 additional countries.
The global Mains Distribution Unit (g-MDU) L3 terminal connection in these systems may become loose, creating an electrical hotspot that can produce smoke and fire. This hazard poses a risk in the hospital technical room where the equipment operates.
Healthcare facilities with affected units should immediately cease use of the systems and contact Philips North America LLC for inspection and remediation. The specific serial numbers of affected units are available from the FDA.
The recalled product
- Product
- Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
- Manufacturer
- Philips North America Llc
- Affected units
- 200
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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