Medical Device Mains Distribution Unit Recall Due to Fire Risk
The Evolution upgrade 3.0T mains distribution unit is being recalled because its L3 terminal connection may become loose, creating a hotspot that could 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: FDA Class II recall involving fire and smoke hazards with potential for property damage and injury. The source describes a risk-of-harm product where no injuries or property damage have been reported, meeting the criteria for High severity.
Plain-English summary
Philips North America LLC is recalling the Evolution upgrade 3.0T mains distribution unit (model numbers 782117 and 782143) due to a defect in the g-MDU (global Mains Distribution Unit) L3 terminal connection. The connection may become loose over time, creating a hotspot that could cause smoke and/or fire.
This recall affects 32 specific units distributed worldwide, including throughout the United States and in multiple countries in Europe and Asia. The affected serial numbers are: 42246, 85713, 42029, 71774, 85668, 85680, 85685, 85694, 85705, 42023, 42024, 42375, 42217, 42402, 71044, 85698, 85700, 85146, 85677, 85699, 71595, 71815, 85649, 42320, 85684, 71836, 85679, 85682, 85697, 85701, 85708, and 85714.
Hospitals and facility managers should immediately verify their inventory against the serial numbers listed above. If your facility has any of the affected units, contact Philips North America LLC for remediation steps to prevent fire and smoke hazards.
The recalled product
- Product
- Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
- Hazard
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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