[pending] Intera 1.5T Master/Nova Product Number: 781106;
Pending LLM rewrite. Source: FDA_DEVICE Z-1933-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
The recalled product
- Product
- Intera 1.5T Master/Nova Product Number: 781106;
- Manufacturer
- Philips North America
- Category
- Medical Device — Devices
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 (4)
- Product Number: 781106
- UDI-DI: no UDI
- Serial Numbers: 8009
- 18863
Distribution
Distributed nationwide across the United States.
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