Philips Intera Achieva 1.5T Pulsar MRI Systems Gradient Coil Fire Risk
Philips is recalling certain Intera Achieva 1.5T Pulsar MRI systems due to a potential component failure in the gradient coil that could generate smoke and/or fire, risking patient and operator injury or death.
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: The FDA classified this as a Class II recall, and the source text explicitly describes potential for death, serious injury (burns, asphyxiation, smoke inhalation), and property damage from a component failure that could generate heat, smoke, and fire. This meets the criterion for Severe (Score 4) as a Class II with significant injury and death potential reported.
Plain-English summary
Philips North America is recalling four units of the Intera Achieva 1.5T Pulsar MRI system (Product Number 781171) distributed worldwide, including in the United States and internationally. The systems have been distributed to locations in Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, South Dakota, and internationally to Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain.
A component failure in the gradient coil of affected systems can potentially act as a heat source and produce smoke and/or fire. If smoke or fire occurs, patients or operators may inhale smoke, suffer burns, or experience asphyxiation, which may lead to injury or even death. This issue could also result in property damage.
Affected units can be identified by Serial Numbers 11044, 11039, 18627, and 11069. Customers who own or operate these systems should contact Philips North America for further guidance on this issue.
The recalled product
- Product
- Intera Achieva 1.5T Pulsar; Product Number: 781171;
- Manufacturer
- Philips North America
- Category
- Medical Device — MRI System
- Hazard
- fire
- smoke-inhalation
- burn-injury
- asphyxiation
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 (6)
- Product Number: 781171
- UDI-DI: no UDI
- Serial Numbers: 11044
- 11039
- 18627
- 11069
Distribution
Distributed nationwide across the United States.
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