Medical Device Safety and Recalls: Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy

A recall has been issued for Brainlab Cranial Image-Guided Surgery (IGS) System. Brainlab is recalling the Cranial 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.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm481966.htm

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