Recall Z-3041-2026
- Recall number
- Z-3041-2026
- 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
- K193454, 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 IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.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.