Philips MRI System Recalled for Potential Fire in Power Distribution Unit
Philips is recalling 2 Achieva 1.5T MRI systems worldwide due to a potential loose connection in the power distribution unit that could 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 medical device recall without reported hospitalizations or incidents. The potential for fire from a loose electrical connection is serious, but the lack of confirmed incidents and the theoretical nature of the hazard result in a severity level 3 classification.
Plain-English summary
Philips North America LLC is recalling 2 units of the Achieva 1.5T Initial MRI system (Model 781178, Serial Numbers 20282 and 20303). These systems have been distributed worldwide, including throughout the United States and in Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.
The g-MDU (global Mains Distribution Unit) L3 terminal connection in these systems may become loose, creating a hotspot. This condition could result in smoke and/or fire in the hospital's technical room.
Healthcare facilities that have received these specific serial numbers should immediately contact Philips North America LLC. The FDA classified this as a Class II recall. Facilities should not continue to operate the affected systems. An authorized Philips service representative must inspect the terminal connection and perform any necessary repairs.
The recalled product
- Product
- Achieva 1.5T Initial system Model Number (REF): 781178
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Medical Imaging
- Hazard
- fire
- electrical-fault
- 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 (2)
- UDI-DI: N/A Serial Numbers: 20282
- 20303
Distribution
Distributed nationwide across the United States.
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