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.
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: 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
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.
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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