N/A 9735894 (UDI 00643169946538)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00643169946538), received between Oct 17, 2018 and Apr 1, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (12 reports).

2 other recalls cover devices cleared under the same FDA submission (K162309); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Excessive Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AN ALLEGED FIRE APPEARED WHILE WORKING ON THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756677 ↗
• MalfunctionMar 2, 2026Display or Visual Feedback Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM DISPLAYED 'NO VIDEO DETECTED' UPON MOVING IT FROM ONE ROOM TO ANOTHER. DURING TROUBLESHOOTING, THE CLINICAL SPECIALIST REPRESENTATIVE (CS) CHANGED THE VIDEO INPUT TO DISPLAY PORT (DP) BUT THE ISSUE PERSISTED. THE CS CHANGED IT BACK TO HIGH-DEFINITION MULTIMEDIA INTERFACE (HDMI).  THE CS RESEATED THE HDMI CABLE FROM THE BACK OF THE MONITOR TO THE COMPUTER AND REBOOTED THE SYSTEM. THIS RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490781 ↗
• MalfunctionFeb 27, 2026Display or Visual Feedback Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT ON BOOT UP, THE SYSTEM DISPLAYED A NO VIDEO DETECTED MESSAGE. THE SURGEON REBOOTED THE MONITOR, WHICH DID NOT RESOLVE THE ISSUE. WHILE THE CLINICAL CONSULTANT (CC) WAS ON SITE, THEY PERFORMED A HARD REBOOT ON THE COMPUTER, WHICH RESOLVED THE ISSUE. THE CC REBOOTED THE SYSTEM SEVERAL TIMES AND WAS UNABLE TO REPLICATE THE INITIAL ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470521 ↗
• MalfunctionDec 29, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN CONTEXT. IT WAS REPORTED THAT THE NAVIGATION SYSTEM HAD SPHERE LOCATION FAILURE. PATIENT PRESENCE NOT PROVIDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905862 ↗
• MalfunctionJul 2, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITOR WAS NOT WORKING. THE MONITOR WAS NOT DISPLAYING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384883 ↗
• MalfunctionApr 22, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A COMMUNICATION ISSUE DETECTED DURING PLANNED MAINTENANCE (PM) WHEN IMPORTING STUDIES FROM THE X-RAY SERVICE. THE DEVICE PASSED ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS)/DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) COMMUNICATION TESTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881644 ↗
• MalfunctionFeb 19, 2025Display or Visual Feedback Problem; Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. THE MONITOR DID NOT RETRIEVE ANY VIDEO SIGNAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417087 ↗
• MalfunctionJan 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PLANNING STATION DISPLAY DID NOT TURN ON WHEN SYSTEM WAS SWITCHED ON.  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208178 ↗
• MalfunctionOct 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT PASSING AN ELECTRICAL SAFETY TEST. THE CURRENT LEAK WAS ABOVE THE LIMIT. THE NEXT STEP WAS TO REPLACE THE COMPUTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395723 ↗
• MalfunctionSep 11, 2024Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) WERE NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. THE SITE ENCOUNTERED AN ISSUE WHERE THE DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) QUERY AND RETRIEVAL FUNCTIONALITY WERE NOT WORKING TO OBTAIN PATIENT DATA FROM THE PACS SERVER. THE FIELD REPRESENTATIVE (REP) RESET ALL NETWORK CONFIGURATIONS AND RECREATED THE NETWORK NODES ON BOTH SIDES OF THE SYSTEM, BOTH THE SYSTEM ITSELF AND THE PACS SERVER. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191410 ↗
• MalfunctionAug 22, 2024Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS ABLE TO DOWNLOAD MAGNETIC RESONANCE IMAGING (MRIS), BUT UNABLE TO DOWNLOAD COMPUTED TOMOGRAPHY (CT) EXAMS. THE SITE RECEIVED, "C-MOVE RESPONSE WITH ERROR STATUS," IN THE LOGS . THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS IMPOSSIBLE TO GRAB DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) FROM THE NAVIGATION SYSTEM BECAUSE DATA PROTECTION REGULATION (RODO) IN THIS HOSPITAL DIDN¿T ALLOW FOR IT. THE SITE SOLVED THE PROBLEMS WITH ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) DICOM SERVER AND THAT WAS REASON OF THIS FAULTY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039756 ↗
• MalfunctionAug 14, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE RECENTLY ENCOUNTERED TECHNICAL ISSUES WITH THE NAVIGATION SYSTEM. IT SEEMED THAT THE MEDTRONIC SYSTEM WOULD FREEZE FREQUENTLY AND OCCASIONALLY ON POWER ON, IT WOULD FAIL TO BOOT UP. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986224 ↗
• MalfunctionAug 8, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AFTER SWITCHING ON THE SYSTEM, IT WOULD NOT START/BOOT. THERE WAS AN ERROR MESSAGE THAT WAS DISPLAYED TO CONTACT "MEDTRONIC SERVICE." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944554 ↗
• MalfunctionMay 14, 2024Display or Visual Feedback Problem; Application Program Problem; Display or Visual Feedback Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITOR PIXELS WERE NOT FUNCTIONAL IN THE AREA WHERE THE LOGIN BOX SHOULD APPEAR. IT WAS NOT POSSIBLE TO LOGIN DUE TO THIS ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313430 ↗
• MalfunctionMar 13, 2024Display or Visual Feedback Problem; Power Problem; Display or Visual Feedback Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EXTERNAL POWER SUPPLY WAS NOT WORKING PROPERLY. THE MONITOR SEEMED TO BE DAMAGED, HAD NO IMAGE. THE POSITIONING SENSOR UNIT (PSU) HAS A LIGHT BUT THE MONITOR HAD NO REACTION. THE PC STATION SEEMED TO BE WORKING. NOT CLEAR IF THE GRAPHICS PRINTED CIRCUIT BOARD (PCB) OF THE PC STATION WAS OK OR NOT. NO WORKING MONITOR AVAILABLE TO TEST EITHER DISPLAY PORT OR DIGITAL VISUAL INTERFACE PORT SIGNALS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895064 ↗
• MalfunctionJan 17, 2024Adverse Event Without Identified Device or Use Problem; Data Problem; Adverse Event Without Identified Device or Use Problem; Data Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE MANUFACTURER REPRESENTATIVE USED THE LINKED THE FIBER TRACTS WITH THE DIFFUSION REFERENCE AS THE MAIN REFERENCE FOR MERGE WITH ALL OF THE IMAGE SUCH AS MRI T1 T2. AFTERWARD THE MANUFACTURER REPRESENTATIVE PLANNED EVERYTHING ON DEEP BRAIN STIMULATION (DBS) SOFTWARE, SUCH AS AC, PC, MIDLINE, LEAD, AND DTI TRACTS. THEN, THE MANUFACTURER REPRESENTATIVE IMPORTED A COMPUTER TOMOGRAPHY (CT) PATIENT IMAGE WITH LEKSELL FRAME. AFTER THE MANUFACTURER REPRESENTATIVE SET THE CT IMAGE AS A REFERENCE FOR MERGING ALL PLANNING IN DBS WAS DISLOCATED. THEREFORE, THE MANUFACTURER REPRESENTATIVE TRIED NOT USE THE LINKED THE FIBER TRACTS WITH THE DIFFUSION REFERENCE AS THE MAIN REFERENCE, AND THEN EVERYTHING BECAME NORMAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530297 ↗
• MalfunctionJan 17, 2024Data Problem; Data Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A MERGE ISSUE WAS FOUND IN APP 2.0.1 THAT CAN BE REPLICATED WITH THE DEMO EXAMS. WORKFLOW WAS AS DESCRIBED, THE DEEP BRAIN STIMULATION (DBS) PLANNING CASE, HAVE MAGNETIC RESONANCE (MR) AND DIFFUSION AND THESE MERGED. CREATED A PLAN ON THE MR. BACK TO IMAGES AND ADDED A FRAME COMPUTER TOMOGRAPHY (CT) SCAN, IN THE MERGE THE CT WAS THE NEW REFERENCE AND MERGE WAS VERIFIED. AT FRAME REGISTRATION TASK, THE PLAN HAD NOW MOVED OUT OF POSITION BY CENTIMETERS. BUT, IF I HAPPEN TO HAVE 2 MR AND DIFFUSION, AND MAKE 1 MR BE THE REFERENCE, AND THE OTHER MR BE THE DIFFUSION REFERENCE AND MERGE THEM, THEN CREATE A PLAN ON THE REFERENCE MR. ADD A FRAME CT, AND MERGE MAKE THE CT BE THE NEW REFERENCE AND VERIFY. AT FRAME REGISTRATION TASK, THE PLAN WAS STILL IN THE CORRECT LOCATION. THE PROBLEM SEEMED TO BE IF THE NAVIGATION AND DIFFUSION REFERENCES WERE THE SAME EXAM, CHANGING THE REFERENCE WOULD MOVE THE PLAN. THE MANUFACTURER REPRESENTATIVE JUST REPLICATED THE ISSUE USING THE DEMO WITH AN MR, DIFFUSION AND CT BONE IN A TUMOR RESECTION WORKFLOW, SO IT WAS UNRELATED TO THE DBS ASPECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530258 ↗
• MalfunctionDec 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE SYSTEM IS STARTED THAT THE SCREEN IS BLACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273512 ↗
• MalfunctionNov 14, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE STATION HAD A BLACK SCREEN AFTER BOOTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131873 ↗
• MalfunctionNov 13, 2023Display or Visual Feedback Problem; Failure to Transmit Record; Communication or Transmission Problem; Display or Visual Feedback Problem; Failure to Transmit Record; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WERE SEVERAL PROBLEMS WITH THE SYSTEM. A BLACK SCREEN WAS EXPERIENCED, BUT IT WAS RESOLVED VIA A REBOOT. THE SYSTEM WAS UNPLUGGED FROM POWER FOR SEVERAL SECONDS, PLUGGED IN AGAIN, AND REBOOTED. THE SYSTEM WAS FUNCTIONAL AT THAT POINT. NETWORK TRANSFER WAS NOT POSSIBLE WITH THE SYSTEM. THE SURGEON TRIED TO EXPORT THE PATIENT TO A USB DRIVE, AND IT DID NOT WORK. THE SYSTEM GOT STUCK WITH 1% PROGRESS. THE SURGEON HAD TO REPLAN THE PATIENT DIRECTLY ON THE NAVIGATION SYSTEM. IT WAS NOTED THAT THE SURGEON LOST ONE HOUR BECAUSE OF THE REPORTED ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125544 ↗
• MalfunctionOct 14, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS WAS NOT RELATED TO A SINGLE EXAM, BUT TO ALL EXAMS WHERE YOU DO THE SAME THING. IT WAS NOT RESOLVED BY UPGRADING THE OPERATING SYSTEM AND SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632377 ↗
• MalfunctionSep 23, 2021Communication or Transmission Problem; Computer Operating System Problem; Communication or Transmission Problem; Computer Operating System Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SYSTEM WAS REPORTED TO WORK SLOWER THAN IT USED TO. THE SITE STATED THAT SOME PATIENTS WOULD SHOW AS CORRUPTED (NOT ABLE TO DELETE, EXPORT OR DO ANYTHING WITH THEM). TROUBLESHOOTING WAS PERFORMED AND IT WAS FOUND THAT A SIMILAR ISSUE WAS REPORTED AT THE SAME SITE WITH ANOTHER NAVIGATION SYSTEM. DURING THE VISIT WITH THE MANUFACTURER REPRESENTATIVE NONE OF THE REPORTED ISSUE WERE NOTICED BUT REPLACED THE SSD AND REINSTALL THE SOFTWARE FOR A PRECAUTION. NO PATIENT PRESENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING A SITE VISIT, THE SITE NOTIFIED THEM THAT THE PLANNING STATION WAS INTERMITTENTLY WORKING SLOWER THAN IT USED TO. DURING THE INITIAL VISIT IT WAS WORKING AS INTENDED AND SINCE THEN THEY HAVEN'T RECEIVE ANY NEW COMPLAINTS. DUE TO SIMILAR COMPLAINTS WHICH HAVE BEEN CONFIRMED AND SOLVED ON THE NAVIGATION SYSTEM AT THAT SAME SITE, THE MANUFACTURER REPRESENTATIVE DECIDED TO REPLACE THE SSD AND REINSTALL THE SOFTWARE OUT OF PRECAUTION TO AVOID FURTHER INTERMITTENT COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520027 ↗
• MalfunctionMay 3, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO SIGNAL ON THE MONITOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760304 ↗
• MalfunctionApr 21, 2021Failure to Shut Off; Application Program Freezes or Fails to Launch; Failure to Shut Off; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WOULD INTERMITTENTLY NOT BOOT. ADDITIONALLY, IT WAS NOTED THAT THE SYSTEM WOULD NOT POWER DOWN AS AN UNSPECIFIED FUNCTION WOULD NOT HALT AND REQUIRED A HARD SHUT DOWN WITH THE POWER BUTTON. TROUBLESHOOTING WAS NOTED TO HAVE REPLACED THE SSD TO RESTORE FUNCTIONALITY AND THE ISSUE WAS CAUSED BY THE SSD. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701559 ↗
• MalfunctionMar 23, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE SYSTEM COULD NOT COMPLETE OPERATING SYSTEM BOOT UP. TROUBLESHOOTING WAS DONE AND THEY TRIED TO REPLACE THE SSD, BUT IT DIDN'T RESOLVE THE ISSUE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PRODUCT WAS NOT SERVICEABLE AND THAT THE NEW PLANNING STATION WOULD BE ORDERED BY THE MARKETING TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555102 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162309. One submission often covers many models, so check the product and lot details in each record.

• Z-1776-2024 · Mar 26, 2024 · Open, Classified
  Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutane
• Z-1995-2020 · Aug 9, 2019 · Terminated
  Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS Licen