MRI System Recalled Due to Loose Terminal Connection Fire Hazard
Philips Ingenia Elition X- MRI systems have a loose terminal connection in the power distribution unit that may create a hotspot and cause smoke or fire in hospital settings. No injuries have been reported.
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 a potential fire and smoke hazard in diagnostic medical equipment used in hospital technical rooms, representing significant risk of harm. However, no injuries, hospitalizations, or actual incidents have been reported, and the hazard is theoretical. The FDA Class II classification combined with lack of reported injuries and incidents places this at High severity.
Plain-English summary
The Ingenia Elition X- Magnetic Resonance (MR) system (Model 781358) is being recalled because the global Mains Distribution Unit (g-MDU) L3 terminal connection may become loose, creating a hotspot that could cause smoke or fire in hospital technical rooms.
One unit with serial number 45030 has been distributed worldwide, including to the United States and countries such as 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.
Healthcare facilities with this MRI system should contact Philips North America LLC immediately to request instructions for remediation or replacement. No injuries or fires have been reported in association with this issue to date.
The recalled product
- Product
- Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358
- Manufacturer
- Philips North America Llc
- Affected units
- 1
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: (01)00884838088115(21) Serial Number: 45030
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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