Philips Panorama HFO MR Systems Loose Terminal Connection May Create Fire Hazard
Philips Panorama HFO MR diagnostic imaging systems (Model 781350) contain a loose terminal connection in the mains distribution unit that may create a hotspot and cause smoke or fire. Approximately 118 units are affected worldwide.
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 Class II FDA medical device recall for a potential fire hazard from a loose electrical connection in hospital equipment. No injuries, illnesses, or fires have been reported, placing this in the High category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling Panorama HFO Magnetic Resonance (MR) diagnostic imaging systems, Model 781350. The recall affects approximately 118 units distributed worldwide, including the United States and multiple countries.
The recalled systems have a loose terminal connection in the g-MDU (global Mains Distribution Unit) L3 component. This loose connection may create a hotspot that could cause smoke or fire to occur in hospital technical rooms.
No illnesses or injuries have been reported to date. Healthcare facilities with affected devices should refer to the FDA recall notice for specific information regarding affected serial numbers.
The recalled product
- Product
- Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350
- Manufacturer
- Philips North America Llc
- Affected units
- 118
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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