Philips Intera Achieva 1.5T MRI systems recalled for potential gradient coil fire
Philips is recalling Intera Achieva 1.5T Pulsar MRI systems due to a gradient coil component defect that can produce smoke and fire. Potential hazards include burns, smoke inhalation, and asphyxiation.
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 a Class II medical device recall with a serious fire hazard. While no injuries or deaths have been reported, the potential for smoke inhalation, burns, and asphyxiation leading to harm exists.
Plain-English summary
Philips North America has recalled Intera Achieva 1.5T Pulsar MRI systems (Product Number 781171) due to a component failure in the gradient coil. This component failure can act as a heat source and produce smoke and/or fire.
The affected systems have been distributed in the United States and internationally. If smoke or fire occurs, risks to patients and operators include inhalation of smoke, burns, and asphyxiation, which may lead to injury or death. Property damage is also possible.
The recalled product
- Product
- Intera Achieva 1.5T Pulsar; Product Number: 781171;
- Manufacturer
- Philips North America
- Hazard
- fire
- burn-injury
- smoke-inhalation
- 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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