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
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.

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