Official recall notice
FDA DeviceClass IINotable
FDA Recall: Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
- Recall date
- 2026-09-02
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential of failing to trigger clinical scan during Bolus Tracking.
Product description
Potential of failing to trigger clinical scan during Bolus Tracking.
Affected products
Device Identifier: (01)00884838085015, (01)00884838105508.