Incisive CT recallZ-2988-2026 · Philips Healthcare (Suzhou) Co., Ltd. · initiated Jun 26, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Healthcare (Suzhou) Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential of failing to trigger clinical scan during Bolus Tracking.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
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.
Recall details
- Recall number
- Z-2988-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2026
- Posted by the FDA
- Aug 21, 2026
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Product code
- JAK
- FDA submissions
- K212441
- Distribution
- U.S. Nationwide and U.S. Territories distribution.
Product description
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Code information (models, lots, serial numbers)
Device Identifier: (01)00884838085015, (01)00884838105508.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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