FDA DeviceClass IINotable

FDA Recall: CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

Date: 2026-04-29
Brand: Integra LifeSciences Corp. (NeuroSciences)
Category: Medical Device
FDA Class: Class II

Description

Software issue that renders the touch screen unresponsive.

Hazard

Software issue that renders the touch screen unresponsive.

Remedy

78 units

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