Device recall
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
- Recall number
- Z-3042-2026
- Event id
- 99784
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Philips North America Llc
- Report date
- Sep 9, 2026
- Posted
- Sep 1, 2026
- Initiated
- Aug 7, 2026
- Center classification date
- Sep 1, 2026
- Product code
- JAK
- Device type
- System, X-Ray, Tomography, Computed
- Reason
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Quantity
- N/A
- Code info
- UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A
- Distribution
- US and US Territories.
- Voluntary or mandated
- FDA Mandated
- Related 510(k)s
- K160743
- Location
- Cambridge, MA, United States