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Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

FDA Recall #Z-2603-2025 — Class II — August 13, 2025

Recall #Z-2603-2025 Date: August 13, 2025 Classification: Class II Status: Ongoing

Product Description

Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.

Reason for Recall

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

Recalling Firm

Philips North America Llc — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3 units

Distribution

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, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

Code Information

1. Model Number: 728325; UDI-DI: N/A; Serial Numbers: 338014, 338028, 338019.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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