Philips North America Llc recalls Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

Recall date

October 29, 2025

Source

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

Recall number

Z-0881-2026

FDA classification

Class II

Brand / firm

Philips North America Llc

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Re…

Why it was recalled

If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

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

What was recalled

Incisive CT; Software Version Number: 4.5, 5.0, 5.1;