Achieva XR Product Numbers recalled over fire hazard

Recall date

May 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Philips North America recalls Achieva XR Product Numbers: (1) 781153, (2) 781253;

Recall number

Z-1928-2025

FDA classification

Class II

Brand / firm

Philips North America

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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