Philips Achieva 3.0T MRI System Recall: Fire Hazard Risk
Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.
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 an FDA Class II recall concerning a potential fire hazard from a loose electrical connection. The source describes a risk of harm (fire and smoke generation) where equipment operates. With no reported injuries or incidents documented in the source material, the recall qualifies as a risk-of-harm product where injury has not yet been reported, scoring as High (3).
Plain-English summary
Philips North America LLC is recalling 386 units of the Achieva 3.0T MRI system due to a potential fire hazard. The affected equipment includes five model numbers (781345, 781344, 781278, 781277, and 781177) and has been distributed worldwide, including throughout the United States and multiple countries across Europe, Asia, and other regions.
The hazard involves the g-MDU (global Mains Distribution Unit) L3 terminal connection in these systems. The connection may become loose, creating an electrical hotspot that may cause smoke or fire to develop in the equipment's technical room. This poses a fire safety risk in healthcare facilities operating the affected systems.
A complete list of affected serial numbers has been provided to the FDA by the manufacturer.
The recalled product
- Product
- Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI System
- Hazard
- fire
- electrical-hazard
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 (4)
- UDI-DI: (1) 781345 N/A
- (2) 781344 N/A
- (3) 781278 (01)00884838004139(21)
- (4) 781277 N/A
Distribution
Distributed nationwide across the United States.
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