Class II

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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips North America Medical Device Recall: Intera 1.5T Master/Nova Product Number: 781106; | SafeCheck