IQon Spectral CT recallZ-2651-2026 · Philips Medical Systems · initiated Jun 11, 2026
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 Medical Systems 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 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-2651-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 11, 2026
- Posted by the FDA
- Jul 27, 2026
- Recalling firm
- Philips Medical Systems
- Quantity
- 42
- Product code
- JAK
- FDA submissions
- K193454
- Distribution
- US Nationwide Distribution including Puerto Rico
Product description
IQon Spectral CT IQon Spectral CT Upgrades
Code information (models, lots, serial numbers)
FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IQon Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed5 recalls7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99352).
- Z-2650-2026 · Open, ClassifiedBrilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
- Z-2652-2026 · Open, ClassifiedIngenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
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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