FDAFDA recall Z-3043-2026 · Sep 9, 2026
Philips North America Llc: Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231 recall
Recall found
Product
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Reason for 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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.
- Quantity
- N/A
- Distribution
- US and US Territories.
- Recalling firm
- Philips North America Llc, Cambridge, MA
- Voluntary or mandated
- FDA Mandated
- Recall started
- 2026-08-07
Source: openFDA enforcement record Z-3043-2026 · search recall number Z-3043-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.