Z-3042-2026 Class II Ongoing
FDA device recall Z-3042-2026 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 Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.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
UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A