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 software is being recalled “due to the potential for incorrect information to display during surgery that may prevent the surgeon from accurately navigating surgical tools inside the patient,” which could result in “damage to the patient’s body, a second, otherwise unnecessary, surgical procedure, or serious life-threatening patient injuries or death,” the recall notice said.
According to the company, the affected Spinal Navigation Software Version 1.0 was manufactured from May 2018 to February 2019 and the recall affects 60 devices in the U.S.
Brainlab AG is a German manufacturer of...
