Medical Device Recall: Intera 1.5T Master/Nova Product Number: 781106;
Philips North America · May 29, 2025
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
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 Affected
NATIONWIDE
Quantity Affected
2 units (US only)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1933-2025
Status: ongoing
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