Recall Z-2988-2026
Philips Healthcare (Suzhou) Co., Ltd. · initiated June 26, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Codes / lots: Device Identifier: (01)00884838085015, (01)00884838105508.
Reason for recall
Potential of failing to trigger clinical scan during Bolus Tracking.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
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.
Details
- Recall number
- Z-2988-2026
- Initiated
- June 26, 2026
- Posted by FDA
- August 21, 2026
- Product code
- JAK – System, X-Ray, Tomography, Computed
- Distribution
- U.S. Nationwide and U.S. Territories distribution.
- Recalling firm
- Philips Healthcare (Suzhou) Co., Ltd., Suzhou, Pingjiang