Warning
Integra LifeSciences Corp. (NeuroSciences) Recalls CUSA Clarity C7000 Console
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1828-2026Medical Device
Integra LifeSciences Corp. (NeuroSciences) Recalls CUSA Clarity C7000 Console
Integra LifeSciences Corp. (NeuroSciences) · Class II — Moderate Risk
Product Description
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Reason for Recall
Software issue that renders the touch screen unresponsive.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide - US Nationwide distribution in the states of MI & NY. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database