Z-2651-2026Class II

IQon Spectral CT IQon Spectral CT Upgrades

Name: Z-2651-2026 IQon Spectral CT IQon Spectral CT Upgrades
Creator: Philips Medical Systems
Published: 2026-06-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-06-11 / Open, Classified

FDA source

PHILIPS MEDICAL SYSTEMS began a recall of IQon Spectral CT IQon Spectral CT Upgrades on 2026-06-11. FDA classified it as Class II and gives the reason as "The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2651-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-11
Posted: 2026-07-27
Recalling firm: Philips North America LLC
Product: IQon Spectral CT IQon Spectral CT Upgrades
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
FDA root cause: Radiation Control for Health and Safety Act
Action: An Electronic Product Radiation Correction letter was issued to its customers describing the product, problem and actions to be taken by its customers. To identify the software version of your product: 1. Click the Help button. 2. Select About and the software version is then displayed. The software version begins with v. 3.You may continue to use your system(s) in accordance with the intended use. 4. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Electronic Product Radiation Correction Letter, understanding of the issues, and required actions to be taken. 5. Circulate this Electronic Product Radiation Correction Letter to all users of this device so that they are aware of the issues. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update to resolve the issues. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 42
Distribution: US Nationwide Distribution including Puerto Rico
Product codes and lots: FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2651-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2650-2026	Class II	Ongoing	FDA Mandated	2026-08-05	2026-07-27
Z-2651-2026	Class II	Ongoing	FDA Mandated	2026-08-05	2026-07-27
Z-2652-2026	Class II	Ongoing	FDA Mandated	2026-08-05	2026-07-27

Product code JAK

K193454Class IIIQon Spectral CTPhilips Medical Systems Nederland B.V. / cleared 2020-01-24

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)