Philips Healthcare (Suzhou) Co., Ltd. recalls Philips Incisive CT with software V4.5&V5.0

Potential of failing to trigger clinical scan during Bolus Tracking.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2988-2026
• FDA 510(k) clearance · K212441The device's official FDA premarket clearance record
• FDA device classification · JAKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips Healthcare (Suzhou) Co., Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.