The following statement was taken, in part from the FDA website: The StealthStation System is used for any medical condition in which the use of stereotactic surgery may be appropriate. This system keeps track of where surgical tools are in relation to a patient’s anatomy by using images of the patient…. Medtronic Navigation is recalling StealthStation S8 Application Version 2.0 and 2.0.1 due to a software glitch that can make the surgical plan data shift location after the initial test is changed. This can cause the surgical plan data to be in an unintended location for the surgery.The use of affected product may cause serious adverse health consequences, including death.There have been no reported injuries. There have been no reports of death.
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