Philips Sonalleve MR HIFU 3.0T diagnostic system fire risk recall
Philips is recalling 4 Sonalleve MR HIFU 3.0T diagnostic systems worldwide due to loose electrical connections in the mains distribution unit that may create fire hazards in hospital settings.
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 an FDA Class II recall involving risk of fire and smoke from loose electrical connections in medical equipment used in hospital settings. While no injuries, fires, or hospitalizations have been reported, the potential for fire in a healthcare facility represents a significant risk-of-harm scenario.
Plain-English summary
Philips North America LLC is recalling 4 units of the Sonalleve MR HIFU 3.0T, a magnetic resonance diagnostic system distributed worldwide including the United States and multiple countries across Europe, Asia, and other regions.
The defect involves the g-MDU (global Mains Distribution Unit) L3 terminal connection, which may become loose and create a hotspot. This loose connection poses a risk of smoke or fire in the hospital's technical room where the equipment operates.
This Class II recall was issued by the FDA due to the electrical hazard and fire risk from the defective terminal connection.
The recalled product
- Product
- Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
- Hazard
- Affected units
- 4
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: N/A Serial Number: 6102 6115 6101 34007
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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