Z-1931-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units (1 US, 2 OUS)
Product Description
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
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.
Distribution Pattern
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.
Code Information
Product Number: 781173; UDI-DI: no UDI; Serial Numbers: 13010, 13006, 21501;