Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Softwa…
Philips North America Llc · Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of t…
Open FDA's page for this record- Cfres ID
- 222479
- Product res number
- Z-3042-2026
- Event date initiated
- 2026-08-07
- Event date posted
- 2026-09-01
- Recall status
- Open, Classified
- Res event number
- 99784
- Product code
- JAK
- 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
- Code info
- UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A
- Firm FEI number
- 3016618143
- Recalling firm
- Philips North America Llc
- Address 1
- 222 Jacobs St
- City
- Cambridge
- State
- MA
- Postal code
- 02141-2289
- Root cause description
- Radiation Control for Health and Safety Act
- Distribution pattern
- US and US Territories.
- 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.
- Action
Philips will inform customers of the issue via an Electronic Product Radiation Correction notification, dated "AUG 2026". Philips will schedule an appointment with remaining customers to update the software free of charge. Customers who need additional information or support concerning this issue should be directed to their local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). Philips reference: 2025-PD-CTAMI-014.
- K numbers
- K160743
- Harmonized identifiers (openFDA)
- Device name
- System, X-Ray, Tomography, Computed
- Medical specialty description
- Radiology
- Regulation number
- 892.1750
- Device class
- 2
- K number
- K213999, K910859, K193073, K063184, K093146, K123500, K090991, K792603, K160350, K033502, K982265, K964890, K120833, K974513, K222819, K884671, K871859, K991766, K812509, K132410, K761330, K151673, K241713, K072606, K142222, K884788, K232155, K942040, K153429, K183202, K073373, K120546, K173821, K240369, K803181, K133424, K974344, K161157, K013214, K894888 +784 more
- Registration number
- 3017425975, 3004056159, 3008632256, 8022257, 3003678543, 3023003446, 3033527283, 3015223550, 3017210169, 9617978, 3027339477, 3001722928, 3013679558, 3019216, 3017426576, 1226188, 3003967489, 3023140882, 3012761544, 3006209933, 9611343, 3015777306, 3033527273, 2520313, 3002808157, 3042175844, 3008355361, 3004083736, 3010398867, 3012453401, 3039211310, 3005930550, 3042172882, 3012938564, 8043933, 3012044688, 3004753774, 3031503890, 3004977335, 3013035022 +126 more
- FEI number
- 3004056159, 3008632256, 3003678543, 3023003446, 3033527283, 3015223550, 3017210169, 3002807880, 3001726808, 3027339477, 3001722928, 3013679558, 3019216, 3017426576, 3004571294, 3003967489, 1000139922, 3023140882, 3012761544, 3006209933, 3033527273, 3015777306, 2520313, 3002808157, 3008355361, 3004083736, 3010398867, 3012453401, 3039211310, 3002619595, 3005930550, 3042172882, 1000514697, 3012938564, 3003757840, 3012044688, 3004753774, 3031503890, 3002807903, 3004977335 +126 more