Z-2988-2026Class II

Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144

Name: Z-2988-2026 Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144
Creator: Philips Healthcare (Suzhou) Co., Ltd.
Published: 2026-06-26
License: https://open.fda.gov/license/

Philips Healthcare (Suzhou) Co., Ltd. / initiated 2026-06-26 / Open, Classified

FDA source

Philips Healthcare (Suzhou) Co., Ltd. began a recall of Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144 on 2026-06-26. FDA classified it as Class II and gives the reason as "Potential of failing to trigger clinical scan during Bolus Tracking". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2988-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-26
Posted: 2026-08-21
Recalling firm: Philips Healthcare (Suzhou) Co., Ltd.
Product: Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Potential of failing to trigger clinical scan during Bolus Tracking.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips notification dated June 26, 2026 will inform customers of the issue via an Electronic Product Radiation Correction notification. Philips will schedule an appointment with 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: 2026-PD-CTAMI-108.
Distribution: U.S. Nationwide and U.S. Territories distribution.
Product codes and lots: Device Identifier: (01)00884838085015, (01)00884838105508.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2988-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2988-2026	Class II	Ongoing	FDA Mandated	2026-09-02	2026-08-21

Product code JAK

K212441Class IIPhilips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. / cleared 2022-04-27

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)