Philips Medical Systems Nederland B.V. recalls Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;

Recall date

February 28, 2025

Source

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

Recall number

Z-1324-2025

FDA classification

Class II

Brand / firm

Philips Medical Systems Nederland B.V.

Sold / distributed

Domestic: MN

Why it was recalled

Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

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

What was recalled

Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;