CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report

Philips CT systems labeled as the following: CT recalled

Philips North America is recalling Philips CT systems labeled as the following: CT 6000, distributed nationwide in the US. The recall was initiated on 13 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. Model Number: 728307; UDI-DI: 00884838104600; Serial Numbers: 87150, 87169, 87118, 87168, 87166, 87164.

Quantity recalled6 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2604-2025
FDA event ID: 97468
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Aug 2025
FDA classified: 19 Sep 2025
Reported: 1 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Aug 2025	Recall initiated by company
19 Sep 2025	Classified by FDA	+37 days
1 Oct 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.

Where it was 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, 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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

1. Model Number: 728307; UDI-DI: 00884838104600; Serial Numbers: 87150, 87169, 87118, 87168, 87166, 87164.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 97468

This product is part of a recall event; the main page for the event is Philips CT systems labeled as the following: Brilliance iCT recalled.

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025	CLASS II	Philips CT systems labeled as the following: Brilliance iCT recalled	Philips North America	Other	Nationwide
1 Oct 2025	CLASS II	Philips CT systems labeled as the following: IQon Spectral CT recalled	Philips North America	Other	Nationwide
1 Oct 2025	CLASS II	Philips CT systems labeled as the following: Big Bore RT recalled	Philips North America	Other	Nationwide
1 Oct 2025	CLASS II	Philips CT systems labeled as the following recalled	Philips North America	Other	Nationwide
1 Oct 2025	CLASS II	Philips CT systems labeled as the following: Brilliance 16 Power recalled	Philips North America	Other	Nationwide
1 Oct 2025	CLASS II	Philips CT systems labeled as the following recalled	Philips North America	Other	Nationwide
1 Oct 2025	CLASS II	Philips CT systems labeled as the following: Ingenuity CT recalled	Philips North America	Other	Nationwide
1 Oct 2025	CLASS II	Philips CT systems labeled as the following recalled	Philips North America	Other	Nationwide
1 Oct 2025	CLASS II	Philips CT systems labeled as the following: Brilliance iCT SP recalled	Philips North America	Other	Nationwide

More recalls from Philips North America

All 531

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel recalled	Philips North America	Device Malfunction	MA
26 Aug 2026Device	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Labeling Errors	Nationwide

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