FDAMay 29, 2025device

Intera 1.5T Achieva IT Nova Product Number: 781175

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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