Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Reported: June 18, 2025 Initiated: May 29, 2025 #Z-1932-2025
Product Description
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Reason for Recall
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.
Details
- Recalling Firm
- Philips North America
- Units Affected
- 1 unit (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.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Intera 1.5T Explorer/Nova Dual Product Number: 781108;. Recalled by Philips North America. Units affected: 1 unit (OUS only).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1932-2025.
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