Brainlab is recalling the Cranial Image-Guided Surgery (IGS) System due to potential inaccuracies in the display by the navigation system compared to the patient anatomy. This could lead to inaccurate, ineffective medical procedures, and serious life-threatening injuries including death.
This recall includes the Brainlab Cranial IGS System and Brainlab Cranial Navigation Systems (all existing versions before Cranial 3.0), distribution dates: May 1996 to May 2015. The number of devices recalled in the U.S is 1021units nationwide. Brainlab neuronavigation combines ease of use with extended functionality tailored to surgeons’ needs.
Brainlab Cranial IGS System shows the area of interest and the position of an instrument relative to the patient’s anatomy to enable minimally invasive surgical procedures. With digital patient data uploaded to the Brainlab Cranial neuronavigation application in the operating room, surgeons can identify their approach before making an incision. Brainlab neuro-navigation tracks tools in real time and displays their position in relation to the patient data. Surgeons are guided through procedures, helping to keep skull openings small and minimize damage to healthy structures.
Brainlab notified customers of the issue on April 22, 2013 and issued an update on May 29, 2015. Customers should adhere to the Instructions for Use supplement document “Measures to Improve Cranial Navigation Accuracy” when using the affected product. Brainlab will provide customers with an updated software version and schedule the update installation starting in September 2015.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Announcement
See the Recall
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