The FDA today labeled a recall of Brainlab’s Cranial image-guided surgery system as a Class I recall over issues with potential inaccuracies in the navigation display.
The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The Brainlab Cranial IGS system provides visualizations for instrument positioning relative to the patient’s anatomy during minimally invasive surgical procedures.
The FDA said that possible navigation inaccuracies could lead to ineffective medical procedures and serious life-threatening injuries, including death.
A total 1021 units are affected by the recall, distributed between May 1996 and May 2015 across Arkansas, California, Colorado, Maryland, North Carolina, Ohio, Pennsylvania and Texas, according to the FDA release.
The company said it will supply customers with updated software versions and began scheduling update installations in September last year.