Philips CT systems labeled as the following recallZ-2601-2025 · Philips North America Llc · initiated Aug 13, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

Philips Medical notified consignees on about 08/11/2025 via letter. Consignees were instructed that they could continue using the affected systems accordance with the intended use and by following the recommendation: Observe the warning listed in Instructions for Use (IFU) and make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. Additionally, consignees were instructed to complete and return the provided response form, to circulate Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue and retain this letter with your system(s) until your system is inspected and corrected if necessary. Philips will contact consignees to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and to inspect the affected system (FCO 72800832) and correct the system if necessary (FCO 72800833).

Recall details

Recall number: Z-2601-2025
Status: Open, Classified
Initiated by the company: Aug 13, 2025
Posted by the FDA: Sep 19, 2025
Recalling firm: Philips North America Llc
Quantity: 81 units
Product code: JAK
FDA submissions: K163711
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.

Product description

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

Code information (models, lots, serial numbers)

1. Model Number: 728332; UDI-DI: 00884838059542; Serial Numbers: 860088, 860023, 860077, 860086, 60019, 860152, 860215, 60031, 60123, 60129, 60152, 860011, 860049, 860019, 860008, 860030, 860025, 860009, 860022, 860013, 860024, 860020, 860036, 860041, 860046, 860055, 860058, 860054, 860073, 860065, 860070, 860072, 860066, 860103, 860076, 860085, 860095, 860102, 860101, 860104, 860175, 860136, 860117, 860120, 860121, 860124, 860125, 860191, 860131, 860150, 860164, 60041, 860207, 60003, 860157, 860167, 860158, 860196, 60012, 860176, 860185, 860168, 860179, 860194, 60010, 60013, 60007, 60001, 395003, 860209, 860208, 60036, 60030, 60027, 60054, 60055, 60053, 60058, 60079, 395005, 60145.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

IQon Spectral CT
Philips Medical Systems Nederland B.V. · System, x-ray, tomography, computed
5 recalls7 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 97468).

Z-2597-2025 · Open, Classified
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model N…
Z-2598-2025 · Open, Classified
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Z-2600-2025 · Open, Classified
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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