Z-3042-2026Class II

Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core...

Name: Z-3042-2026 Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core...
Creator: Philips North America Llc
Published: 2026-08-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-08-07 / Open, Classified

FDA source

Philips North America Llc began a recall of Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x on 2026-08-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3042-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-07
Posted: 2026-09-01
Recalling firm: Philips North America LLC
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
Product code: JAK System, X-Ray, Tomography, Computed
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.
FDA root cause: Radiation Control for Health and Safety Act
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.
Distribution: US and US Territories.
Product codes and lots: UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3042-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3040-2026	Class II	Ongoing	FDA Mandated	2026-09-09	2026-09-01
Z-3041-2026	Class II	Ongoing	FDA Mandated	2026-09-09	2026-09-01
Z-3042-2026	Class II	Ongoing	FDA Mandated	2026-09-09	2026-09-01
Z-3043-2026	Class II	Ongoing	FDA Mandated	2026-09-09	2026-09-01

Product code JAK

K160743Class IIPhilips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. / cleared 2016-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)