Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CT 5300 Recalled by Philips North America Llc Due to If the screws of tube heat exchanger on...

Date: October 29, 2025
Company: Philips North America Llc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America Llc directly.

Affected Products

CT 5300; Software Version Number: 4.5, 5.0, 5.1;

Quantity: 6 units (OUS only)

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America Llc

Philips North America Llc has 301 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report