Recall Z-3042-2026

Recall number
Z-3042-2026
Event number
99784
Firm
Philips North America Llc
Firm FEI
3016618143
Product code
JAK
Status
Open, Classified
Initiated
2026-08-07
Posted
2026-09-01
Root cause
Radiation Control for Health and Safety Act
510(k) numbers
K160743, K134025, K251645, K924082, K812509, K012385, K863935, K080540, K131431, K780480, K090173, K911387, K761330, K242411, K944326, K092365, K201188, K882022, K802206, K984634, K173607, K212067, K253173, K073346, K013381, K020796, K103489, K080581, K221727, K151752

Product#

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.