BRAINLAB ISSUES CLASS 1 RECALL OF ITS SPINAL NAVIGATION SOFTWARE (Orthopedics This Week)
Definition: A Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The Brainlab Spine & Trauma 3D Navigation software, which controls the Brainlab Spine & Trauma Navigation System, has faults which could cause a surgeon to see the operating space incorrectly and cause serious injury or death to patients, the Food and Drug Administration (FDA) announced April 15.
The ...
