Intera 1.5T Omni/Stellar recall
Intera 1.5T Omni/Stellar; Product Number: 781104;
Why was Intera 1.5T Omni/Stellar recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Number: 781104; UDI-DI: no UDI; Serial Numbers: 10403, 18969;
- Product
- Intera 1.5T Omni/Stellar; Product Number: 781104;
- Recalling firm
- Philips North America
- Quantity
- 2 units (OUS only)
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.
- Recall date
- June 18, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)