Medical MR System Electrical Terminal Connection May Create Fire Hazard
A Philips Achieva 3.0T for PET MR diagnostic system (Serial 43006) may have a loose mains distribution unit terminal that could overheat and cause smoke or fire.
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 device with potential fire and smoke hazard. No injuries or illnesses have been reported, and the hazard is theoretical (the device 'may' cause fire/smoke rather than documented incidents). Per the rubric, when no harm is reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
This is an FDA Class II medical device recall. The product is a Philips Achieva 3.0T for PET Magnetic Resonance system (model 781477), a diagnostic medical imaging device. Serial number 43006 has been identified with a potential defect.
The hazard involves the g-MDU (global Mains Distribution Unit) L3 terminal connection, which may become loose and create a hotspot. This could cause smoke or fire in the hospital's technical room. The device has worldwide distribution, including throughout the United States.
Hospitals and healthcare facilities using this equipment should contact Philips North America Llc for information on the identified defect and any corrective actions.
The recalled product
- Product
- Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- smoke
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 Numbers: 43006
Distribution
Distributed nationwide across the United States.
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