FDA Medical devices recall ·
Philips Brilliance recall
- Recall number
- Z-3040-2026
- Date
- (initiated August 7, 2026)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.
Distribution
US and US Territories.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3040-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.