Philips Achieva 1.5T MR Systems: Loose Terminal Connection Fire Risk
Philips is recalling Achieva 1.5T MR diagnostic systems worldwide due to a potential loose connection in the mains distribution unit that could create a hotspot and cause smoke or fire in hospital technical rooms.
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 device recall involving a potential fire hazard in hospital technical rooms. However, no incidents, injuries, or deaths have been reported. The hazard is theoretical, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling Achieva 1.5T Conversion magnetic resonance (MR) systems used for diagnostic imaging. The recall affects 140 units distributed worldwide, including across the United States. The hazard involves the g-MDU (global Mains Distribution Unit) L3 terminal connection, which may become loose and create a hotspot capable of causing smoke or fire in the hospital's technical room.
The recall applies to two model numbers: 781283 and 781346. Affected units are identified by specific serial numbers provided by the manufacturer. The systems have been distributed to hospitals and medical facilities in the United States and internationally, including Austria, Belgium, Canada, China, and 22 other countries.
Healthcare facilities operating these systems should contact Philips North America LLC immediately for remediation instructions. The manufacturer has classified this as a Class II recall. No incidents or injuries have been reported as of the recall announcement.
The recalled product
- Product
- Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- smoke
- electrical-hazard
Distribution
Distributed nationwide across the United States.
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