Philips North America Llc recalls Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

Recall date

August 13, 2025

Source

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

Recall number

Z-2602-2025

FDA classification

Class II

Brand / firm

Philips North America Llc

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Maurit…

Why it was recalled

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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

What was recalled

Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.