Z-1003-2026Class II

Philips Incisive CT

Name: Z-1003-2026 Philips Incisive CT
Creator: Philips Healthcare (Suzhou) Co., Ltd.
Published: 2025-12-03
License: https://open.fda.gov/license/

Philips Healthcare (Suzhou) Co., Ltd. / initiated 2025-12-03 / Open, Classified

FDA source

Philips Healthcare (Suzhou) Co., Ltd. began a recall of Philips Incisive CT on 2025-12-03. FDA classified it as Class II and gives the reason as "Potential for incomplete scan due to unstable connection inside of floating sensor". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1003-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-03
Posted: 2026-01-08
Recalling firm: Philips Healthcare (Suzhou) Co., Ltd.
Product: Philips Incisive CT
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Potential for incomplete scan due to unstable connection inside of floating sensor.
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips will send a customer notification to the existing 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 contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install a hardware solution that will change the method of connection for the rear handle floating sensor. 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-109 or FCO72800843.
Quantity in commerce: 35
Distribution: U.S. and U.S. territories
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1003-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1003-2026	Class II	Ongoing	FDA Mandated	2026-01-14	2026-01-08

Product code JAK

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)