Achieva XR Product Numbers: (1) 781153, (2) 781253;

Reason: 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.

Code information: Product Numbers: (1) 781153, (2) 781253; UDI-DI: (1) no UDI, (2) no UDI; Serial Numbers: All serial numbers;

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.