Recalls for Nystagmograph

The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.

Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR environment.

The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.