Philips SmartPath dStream Gradient Coil Fire Risk Recall
Philips is recalling the SmartPath dStream for 1.5T due to potential fire and smoke hazard in the gradient coil component. Users face risks of smoke inhalation, burns, 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: FDA Class II medical device with serious potential hazards (fire, smoke, burns, asphyxiation leading to possible death) but no reported illnesses or injuries. Per rubric, theoretical hazards without reported harm in Class II devices score at most High (3).
Plain-English summary
Philips North America is recalling the SmartPath to dStream for 1.5T (Product Number: 782146). This is an MRI gradient coil component used in medical imaging systems.
A component failure in the gradient coil can act as a heat source and potentially produce smoke and/or fire. If this occurs, patients and operators face risks including smoke inhalation, burns, and asphyxiation, which may result in serious injury or death. Property damage is also possible.
The affected devices have been distributed worldwide, including in the United States in AZ, CA, DE, MA, MI, NE, NY, and SD, as well as Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain.
Facilities using this device should immediately stop use and contact Philips North America for further instructions.
The recalled product
- Product
- SmartPath to dStream for 1.5T¿; Product Number: 782146;
- 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 (3)
- Product Number: 782146
- UDI-DI: no UDI
- Serial Number: 13013
Distribution
Distributed nationwide across the United States.
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