Philips Incisive CT
FDA device recall Z-1003-2026 · posted 2026-01-08 · Open, Classified
Recall details
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd.
- Reason for recall
- Potential for incomplete scan due to unstable connection inside of floating sensor.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 35
- Distribution
- U.S. and U.S. territories
- Date initiated
- 2025-12-03
- Date posted
- 2026-01-08
- Location
- Suzhou, Pingjiang, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Philips Incisive CT (K212441) | Philips Healthcare (Suzhou) Co., Ltd. | 2022-04-27 |
| Philips Incisive CT (K180015) | Philips Healthcare (Suzhou) Co., Ltd. | 2018-03-20 |