FDA Class I Recall: Brainlab Cranial Image-Guided Surgery System

The Food and Drug Administration (FDA) has issued a Class I Recall of all Brainlab Cranial Image-Guided Surgery Systems before version 3.0. This comes after findings exposed errors in the navigation system that can lead to serious injury and/or death.

The potential for errors in navigation system display in comparison to a patient’s anatomy can lead to life-threatening injuries, including death. Initial inaccuracy reports were supplied to Brainlab in April 2013. Updated information was forwarded to the company in May 2015.

Updates to 1,021 systems are being completed in the following states:

  • Arkansas
  • California
  • Colorado
  • Maryland
  • North Carolina
  • Ohio
  • Pennsylvania
  • Texas

The systems in question were sold to medical facilities in the states listed above. If systems older than 3.0 are still in use, it is suggested that the equipment cease from use until notification that system software updates have been completed for your specific device/s.

If you or a family member have suffered a significant injury due to the use of Brainlab’s Cranial IGS System, you may be entitled to compensation. Contact the attorneys at Harman Law LLC to discuss your potential claim. Our law firm offers a free, no cost and no obligation consultation for all of our clients and their families. Call us today at 1-888-55-HARMAN or 404-554-0777 to schedule your consultation.