FDA Slaps BrainLAB AG's Cranial IGS System with a Class I Recall
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 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.