Z-3155-2026

Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

Name: Z-3155-2026 Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Creator: Philips North America Llc
Published: 2026-08-18
License: https://open.fda.gov/license/

Philips North America Llc / initiated 2026-08-18 / Open, Classified

FDA source

Recall record

Recall number: Z-3155-2026
Status: Open, Classified
Initiated: 2026-08-18
Posted: 2026-09-29
Recalling firm: Philips North America Llc
Product: Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips sent an Electronic Product Radiation Correction notification dated August 18, 2026 to the users of the affected systems to alert them of the issue and provide the actions that should be taken in order to prevent risks to patients. Philips will schedule an appointment with customers to install a software solution free of charge.
Quantity in commerce: 62
Distribution: U.S. and U.S. Territories.
Product codes and lots: UDI: (01)00884838101111

Product code JAK

K244008Class IISpectral CTPhilips Medical Systems Technologies , Ltd. / cleared 2025-05-16

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 2026-10-02. View this recall on fda.gov (opens on fda.gov)