Philips Intera 1.5T Achieva Nova MRI Systems Gradient Coil Fire Risk
Philips is recalling certain Intera 1.5T Achieva Nova MRI systems due to a gradient coil component that can overheat, potentially causing smoke or fire with risk of burns, smoke inhalation, or asphyxia.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a medical device where the hazard explicitly includes potential for serious injury (burns, asphyxia) and death. Although no illnesses have been reported, the source text identifies death as a potential risk, which under the severity rubric warrants a Severe classification for Class II recalls with injury/death potential.
Plain-English summary
Philips North America is recalling specific units of the Intera 1.5T Achieva Nova MRI system (Product Number 781172). A component failure in the gradient coil of affected systems can act as a heat source and potentially produce smoke and/or fire.
If smoke or fire occurs, patients and operators may be exposed to smoke inhalation, burns, and asphyxia, which could result in injury or death. The issue could also cause property damage.
Affected units are identified by the following serial numbers: 21218, 21217, 21216, 21289, 21349, 12146, 12063, 12086, 20069, 21027, 21198, 12099, 18641, 21476, 18623, and 12078. A total of 16 units have been identified worldwide, including 1 unit in the United States distributed across AZ, CA, DE, MA, MI, NE, NY, and SD.
Facilities with affected systems should contact Philips immediately regarding repair or replacement options.
The recalled product
- Product
- Intera 1.5T Achieva Nova Product Number: 781172;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI Equipment
- Hazard
- fire
- burn-injury
- smoke-inhalation
- asphyxia
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 (18)
- Product Number: 781172
- UDI-DI: no UDI
- Serial Numbers: 21218
- 21217
- 21216
- 21289
- 21349
- 12146
- 12063
- 12086
- 20069
- 21027
- 21198
- 12099
- 18641
- 21476
- 18623
- 12078
Distribution
Distributed nationwide across the United States.
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