The Brainlab Cranial IGS (Image Guided Surgery) System has been recalled because inaccuracies in the navigation system display could lead to inaccurate medical procedures. This could result in life-threatening injuries or death.
Brainlab Cranial IGS System shows the surgeon the area being operated on and the position of an instrument relative to the patient’s anatomy to enable minimally invasive surgical procedures. The imaging system guides the surgeon through the procedure, helping to keep skull openings small and minimize damage to healthy brain structures, the company says.
The recall includes about 1021 units distributed nationwide from May 1996 to May 2015. All existing versions of the cranial navigation system before Cranial 3.0 are included in the recall. The Food and Drug Administration (FDA) has categorized this as a Class I recall, the most serious recall class. Use of the Brainlab Cranial IGS System may cause serious injury or death.
Brainlab notified customers of the display problem on April 22, 2013 and issued an update on May 29, 2015. The recall notice was updated again on January 15, 2016. Brainlab notified customers of the problem and said customers should adhere to the Instructions for Use supplement document “Measures to Improve Cranial Navigation Accuracy” when using the recalled IGS devices.
Brainlab will provide customers with an updated software version and schedule the update installation starting in September 2015.
Customers can direct questions to the Brainlab Customer Hotline at 1-800-597-5911 or they can send email to support@Brainlab.com.
from Parker Waichman http://www.yourlawyer.com/blog/class-1-recall-for-brainlab-cranial-image-guided-surgery-system-because-of-navigation-inaccuracy/
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