Philips Brilliance CT 64 Medical Scanner Recall: Unintended Radiation Risk
Philips recalls specific models of Brilliance CT 64 scanners due to potential radiation performance issues that could affect equipment safety. Affected units include Channel Product Code 728231 and Upgrades Product Code 728232.
Lower-risk recall
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
What happened, in plain English
Philips is recalling certain models of Brilliance CT 64 medical scanners because of an unintended radiation issue that could affect equipment performance. This recall affects healthcare facilities using these specific scanner models. Read more at govinfonow.com/recall/843280-philips-brilliance-ct-64-medical-scanner-recall-unintended-radiation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/843280-philips-brilliance-ct-64-medical-scanner-recall-unintended-radiation-risk · Updated September 16, 2026 · FDA enforcement record: FDA #Z-3043-2026
Cite this page
“Philips Brilliance CT 64 Medical Scanner Recall: Unintended Radiation Risk.” GovInfoNow, updated September 16, 2026. https://govinfonow.com/recall/843280-philips-brilliance-ct-64-medical-scanner-recall-unintended-radiation-risk. Based on FDA recall #Z-3043-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3043-2026%22&limit=1).
Why it’s dangerous
The scanners could have unintended radiation performance issues that might affect equipment safety. This means the scanners might not function properly, potentially leading to inaccurate imaging results or other operational problems.
Who’s affected
Healthcare facilities using Philips Brilliance CT 64 scanners with Channel Product Code 728231 or Upgrades Product Code 728232 are most at risk. Patients and staff using these scanners may be affected if the equipment malfunctions.
How to tell if you have this one
Check for Channel Product Code 728231 or Upgrades Product Code 728232 on the scanner. The software version should be 4.1.10.x or the UDI (01)00884838083325 for Channel models.
- Brand
Philips- Product
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US and US Territories.
| Recall number | Product, codes & lots |
|---|---|
| Z-3040-2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.; UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A. |
| Z-3041-2026 | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x; UDI:N/A |
| Z-3042-2026 | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x; UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A |
| Z-3043-2026 | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x; Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A. |
What to do — step by step
Check Scanner Details
Identify the product code and software version on your scanner to confirm if it's affected.
How this recall unfolded
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3043-2026 (August 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3043-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 16, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.