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Philips North America recalls Intera Achieva 1.5T Pulsar; Product Number: 781171;
Recalled June 18, 2025 · FDA recall Z-1935-2025 · Philips North America
Hazard
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. · FDA Class II
Units
4 units (1 US, 3 OUS)
Sold at
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.
Description
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.
Product
Intera Achieva 1.5T Pulsar; Product Number: 781171;
Manufacturer(s)
Philips North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →