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Open, Classified

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

FDA Recall Z-2988-2026 · Posted 2026-08-21

Recalling FirmPhilips Healthcare (Suzhou) Co., Ltd.
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2026-06-26

Reason for Recall

Potential of failing to trigger clinical scan during Bolus Tracking.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

U.S. Nationwide and U.S. Territories distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212441Philips Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · 2022-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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