ClearanceBrief
Recall Z-1003-2026 ยท JAK System, X-Ray, Tomography, Computed

Philips Healthcare (Suzhou) Co., Ltd.

Philips Incisive CT

DateJan 8, 2026 (initiated Dec 3, 2025)
StatusOpen, Classified
ReasonPotential for incomplete scan due to unstable connection inside of floating sensor.
Root causeRadiation Control for Health and Safety Act
ActionPhilips 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 Solu
Quantity35
DistributionU.S. and U.S. territories
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K180015Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd., Mar 20, 2018
K212441Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd., Apr 27, 2022