Magnetic Resonance System Loose Terminal Connection May Cause Fire
Philips MR RT imaging systems may have loose electrical connections that could cause smoke or fire in hospital technical rooms. Two units with serial numbers 45 and 47 are affected worldwide.
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: FDA Class II recall of a medical device with potential fire and smoke hazard from a loose electrical connection. No illnesses, injuries, or deaths reported; the hazard represents a risk-of-harm in a critical medical environment.
Plain-English summary
Philips North America LLC is recalling its MR RT (Magnetic Resonance) imaging systems, Model 781439, serial numbers 45 and 47. These medical electrical systems are indicated for diagnostic use in hospitals. The recall addresses a potential fire hazard involving the device's power distribution unit.
The global Mains Distribution Unit (g-MDU) L3 terminal connection may become loose, creating an electrical hotspot. A loose connection of this type may cause smoke or fire to develop in the hospital's technical room where the equipment is installed. No illnesses or injuries have been reported.
The two affected units have been distributed worldwide, including throughout the United States and to multiple countries in Europe, Asia, and other regions. Healthcare facilities operating these systems should contact Philips North America LLC for inspection and remediation instructions.
The recalled product
- Product
- MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- smoke
- electrical-hazard
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 (2)
- UDI-DI: N/A Serial Numbers: 45
- 47
Distribution
Distributed nationwide across the United States.
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