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Brilliance iCT recallZ-2650-2026 · Philips Medical Systems · initiated Jun 11, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Philips Medical Systems or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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 clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

FDA root cause category: Radiation Control for Health and Safety Act

What the company is doing

An Electronic Product Radiation Correction letter was issued to its customers describing the product, problem and actions to be taken by its customers. To identify the software version of your product: 1. Click the Help button. 2. Select About and the software version is then displayed. The software version begins with v. 3.You may continue to use your system(s) in accordance with the intended use. 4. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Electronic Product Radiation Correction Letter, understanding of the issues, and required actions to be taken. 5. Circulate this Electronic Product Radiation Correction Letter to all users of this device so that they are aware of the issues. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update to resolve the issues. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).

Recall details

Recall number
Z-2650-2026
Status
Open, Classified
Initiated by the company
Jun 11, 2026
Posted by the FDA
Jul 27, 2026
Recalling firm
Philips Medical Systems
Quantity
128
Product code
JAK
FDA submissions
K250648
Distribution
US Nationwide Distribution including Puerto Rico

Product description

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades

Code information (models, lots, serial numbers)

FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

1 device cleared under K250648 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99352).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page