Philips Incisive CT recallZ-1003-2026 · Philips Healthcare (Suzhou) Co., Ltd. · initiated Dec 3, 2025
Class II Open, Classified All recalls posted in January 2026
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 for incomplete scan due to unstable connection inside of floating sensor.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
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.
Recall details
- Recall number
- Z-1003-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Dec 3, 2025
- Posted by the FDA
- Jan 8, 2026
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Quantity
- 35
- Product code
- JAK
- FDA submissions
- K180015, K212441
- Distribution
- U.S. and U.S. territories
Product description
Philips Incisive CT
Code information (models, lots, serial numbers)
N/A
Other devices under the same FDA submission
1 device cleared under K180015, K212441 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
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 18, 2026. Text above is shown as published by the FDA.
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