Z-3043-2026 Class II Ongoing
FDA device recall Z-3043-2026 was initiated by Philips North America Llc on August 7, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- August 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- N/A
Product Description
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.
Distribution Pattern
US and US Territories.
Code Information
Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.