MR Imaging System Recall for Loose Electrical Terminal Connection Fire Risk
Philips AchievaXR MR systems may have loose terminal connections in the power distribution unit that could create hotspots and cause smoke or fire. The FDA has recalled 35 affected units 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: This is a Class II medical device recall for a potential fire and smoke hazard from a loose electrical terminal connection. The recall does not report any injuries or incidents. This represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity classification.
Plain-English summary
The FDA has issued a Class II recall for Philips AchievaXR MR (Magnetic Resonance) systems, model 781253, affecting 35 units with identified serial numbers. These diagnostic imaging systems are used in hospital settings.
The recalled systems contain a g-MDU (global Mains Distribution Unit) L3 component with a terminal connection that may become loose, creating a hotspot that may cause smoke or fire. This fire and smoke hazard prompted the recall.
The affected systems have been distributed worldwide, including across the United States and in 28 additional countries including Canada, Germany, France, Japan, Spain, the United Kingdom, and others. Facilities with equipment matching the specific serial numbers listed in this recall are affected by this notice.
The recalled product
- Product
- AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
- Manufacturer
- Philips North America Llc
- Category
- Medical Device
- Hazard
- fire
- smoke
- electrical-hazard
Distribution
Distributed nationwide across the United States.
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