FDA Medical devices recall ·
Intera 1.5T Explorer/Nova Dual Product Number: 781108 recall
- Recall number
- Z-1932-2025
- Date
- (initiated May 29, 2025)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit (OUS only)
- Hazard tags
- Fire Burn Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Number: 781108; UDI-DI: no UDI; Serial Number: 9025;
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.
States: Arizona California Delaware Massachusetts Michigan Nebraska New York South Dakota
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1932-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.