StealthStation S8 Platform 9735667 (UDI 00643169876972)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169876972), received between Nov 20, 2018 and Dec 3, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Application Program Problem; Connection Problem; Application Program Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT LOCALIZER FAULTED WAS INTERMITTENTLY DISPLAYED AND THE SIDE EMITTER WAS REPLACED. SIDE EMITTER CABLE SEEMED SUSPECT. THERE WAS NO PATIENT INVOLVEMENT. THE CABLE ON THE SIDE EMITTER WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708266 ↗
• MalfunctionAug 29, 2025Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER FAULTED OPTICALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926795 ↗
• MalfunctionMay 8, 2025Mechanical Problem; Application Program Problem; Unexpected Shutdown; Mechanical Problem; Application Program Problem; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SITE WAS HAVING TROUBLE WITH AN ERROR MESSAGE (FAULTY LOCALIZER) WHILE USING EM, AND THE POWER KEPT CUTTING OUT AND THEY HAD TO SWITCH OUTLETS X 3 IN A CASE TO MAKE IT WORK. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT WAS OBSERVED BEFORE THE PROCEDURE STARTED. ANOTHER NAVIGATION SYSTEM UNIT AT THE ACCOUNT WAS USED THAT WAS FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987185 ↗
• MalfunctionJan 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. UPON FOLLOW-UP WITH THE ACCOUNT, THIS CASE TOOK PLACE AFTER HOURS WITH INEXPERIENCED SUPPORT STAFF. WHEN DISCUSSED WITH ACCOUNT AND REVIEWING THE NAVIGATION SYSTEM THERE WERE NO CLEAR ISSUES PRESENT. THE MEDTRONIC REPRESENTATIVE (REP) BELIEVED THE ISSUE WITH REGISTRATION WAS REGARDING LINE OF SIGHT WITH THE CAMERA CART MAY HAVE BEEN INTERRUPTED DURING TRACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163840 ↗
• MalfunctionOct 8, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS DROPPED AND IT WAS NO LONGER FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20400683 ↗
• MalfunctionJul 3, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING A LOCALIZER FAULT ERROR. THE ONLY WAY THE SYSTEM WORKED AGAIN WAS WHEN THEY CLICKED THE POWER BUTTON AND RESET THE ENTIRE NAVIGATION SYSTEM. THERE WAS A PATIENT PRESENT WHEN THE REPORTED ISSUE OCCURRED, BUT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668293 ↗
• MalfunctionJan 23, 2024Power Problem; Unexpected Shutdown; Power Problem; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT  THE SYSTEM HAD A BATTERY ISSUE. WHILE PERFORMING A PLANNED MAINTENANCE ON THE SYSTEM, THE MAIN CART LOST POWER WHILE THE CAMERA CART WAS STILL FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562710 ↗
• MalfunctionOct 10, 2023Application Program Problem; Connection Problem; Application Program Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A LOCALIZER FAULTED. WHILE PERFORMING A PLANNED MAINTENANCE, THE AMBER LIGHT ON THE CAMERA WAS ILLUMINATED. THE MANUFACTURER REPRESENTATIVE (REP) OPENED THE NDITOOLBOX AND NOTICED THAT THE BUMP AND STORAGE TEMPERATURE FAULT STATUSES WERE TRIGGERED. THE REP LOGGED INTO THE CLINICAL APPLICATION AND REPORTED THAT INSTRUMENTS COULD BE TRACKED USING THE CAMERA, BUT THE MESSAGE "LOCALIZER FAULTED" WAS DISPLAYED. TROUBLESHOOTING WAS PERFORMED AND A REBOOT DID NOT RESOLVE THE ISSUE, CONFIRMED AMBER LIGHT WAS STILL ILLUMINATED AND "LOCALIZER FAULTED" WAS DISPLAYED. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THAT THIS WAS A CAMERA ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904276 ↗
• MalfunctionOct 6, 2023Unexpected Shutdown; Unexpected Shutdown

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM'S MAIN CART UNEXPECTEDLY POWERED DOWN, AND THE CAMERA CART LOST CONNECTION. THE MANUFACTURER REPRESENTATIVE (REP) REBOOTED THE SYSTEM, AND THE SAME ISSUE OCCURRED AGAIN. THE REP THEN ATTEMPTED A SECOND REBOOT USING A DIFFERENT OUTLET, AND THE CAMERA CART WOULD NOT POWER ON AT ALL. DURING TROUBLESHOOTING, TECHNICAL SERVICES (TS) HAD THE REP DISCONNECT THE SYSTEM FROM AC POWER, DISCONNECT THE CAMERA CART FROM THE MAIN CART, AND HOLD DOWN EACH POWER BUTTON FOR FIFTEEN SECONDS. UPON PLUGGING THE SYSTEMS BACK INTO EACH OTHER AND AC POWER, IT BOOTED NORMALLY. THE SITE ELECTED TO CONTINUE THE PROCEDURE WITH A DIFFERENT NAVIGATION SYSTEM. THE PROBABLE CAUSE WAS SUSPECTED TO BE RELATED TO THE MAIN CART UNINTERRUPTABLE POWER SUPPLY (UPS) AND BATTERY CONNECTION. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886106 ↗
• MalfunctionMar 27, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  2023-FEB-27, 00762158 (HCP, FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THAT POWER CABLE WAS DAMAGED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619293 ↗
• MalfunctionMar 9, 2023Application 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 SYSTEM BOOTED TO A "LOCALIZER FAULTED" MESSAGE. MULTIPLE REBOOTS DID NOT RESOLVE THE ISSUE. THE SITE SWAPPED TO A DIFFERENT NAVIGATION SYSTEM FOR THE PROCEDURE. THIS WAS DISCOVERED BEFORE THE PATIENT WAS BROUGHT INTO THE ROOM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512968 ↗
• MalfunctionMar 8, 2023Electrical /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 POWER CABLE WAS DAMAGED. THE CABLE CASING WAS STRIPPED ON THE POWER CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501951 ↗
• MalfunctionMar 6, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS APPROXIMATELY A FIVE MINUTE DELAY TO THE CRANIOTOMY PROCEDURE DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486360 ↗
• MalfunctionFeb 14, 2023Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM POWERED DOWN SEVERAL TIMES DURING A PROCEDURE. THE CUSTOMER STATED THAT THE PROCEDURE "WAS NOT VERY LONG" BUT THE SYSTEM STILL POWERED DOWN. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE WAS A CRANIAL PROCEDURE. THE SYSTEM WAS PLUGGED IN TO A KNOWN FUNCTIONAL OUTLET AT THE TIME THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371765 ↗
• MalfunctionJan 30, 2023Environmental Compatibility Problem; Application Program Freezes or Fails to Launch; Environmental Compatibility Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT AFTER REGISTRATION THE CAMERA CART ON THIS SYSTEM TURNED OFF. THE MAIN CART REMAINED ON, BUT PULLING IN A DIFFERENT CAMERA CART DID NOT RESOLVE. THE LOCAL REPRESENTATIVE (CC) ALSO TRIED A NEW UMBILICAL WITH NO CHANGE. THE CAMERA CART MONITOR WAS OFF AND THE CAMERA ITSELF HAD NO LIGHTS AND NO LASER DISPLAYED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE CC CALLED TO TROUBLESHOOT THE SYSTEM FURTHER. HOWEVER, THE OTHER NAVIGATION SYSTEM WAS UNAVAILABLE THEN, AND THE CC HAD NO TOOLS TO REMOVE THE SYSTEM COVERS. AT THE TIME OF THE CALL, THE NAVIGATION SYSTEM MAIN WAS POWERED ON, BUT THE CAMERA CART WAS OFF EVEN THOUGH THEY WERE BOOTED TOGETHER. THE CAMERA CART DID NOT RESPOND TO REBOOTING THE MAIN CART. THE SITE AND CC TURNED OFF THE MAIN CART AND LEFT IT UNPLUGGED FROM THE WALL FOR APPROXIMATELY 30 SECONDS. THIS RESOLVED THE ISSUE OF THE CAMERA CART NOT BOOTING. THE ORIGINAL ISSUE SEEMED TO BE RESOLVED. AFTER THEY BOOTED THE APPLICATION AND STAYED ON THE REGISTRATION SCREEN FOR ABOUT 5 MINUTES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264789 ↗
• MalfunctionJun 9, 2022Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AFTER PERFORMING POINT MERGE REGISTRATION ON THE SPINE, THEY PROCEEDED TO NAVIGATE AND NONE OF THE INSTRUMENTS WOULD NAVIGATE. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THEY WOULD TRACK IN THE TRACKING VIEW. AT THIS POINT, THE SURGEON JUST DECIDED TO USE ANOTHER NAVIGATION SYSTEM THAT WAS ON SITE. THE USE OF THE NAVIGATION SYSTEM WAS ABORTED. THIS CAUSED A 10 MINUTE DELAY TO THE CASE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. (B)(6) 2022 INTERFACE UPDATE DETAILS (REP, FOR): ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT WHILE TROUBLESHOOTING AFTER THE CASE, THE ONLY OPTION TO 'NAVIGATE ONLY' WHEN THE FOOTSWITCH WAS PRESSED WAS ACCIDENTALLY TURNED ON. THE REP CHANGED IT BACK TO CONTINUOUS, AND THE SYSTEM WAS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644829 ↗
• MalfunctionMay 24, 2022Display or Visual Feedback Problem; Environmental Compatibility Problem; Display or Visual Feedback Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITORS OF THE NAVIGATION SYSTEM "WENT BLACK" WITHOUT PROMPT FROM THE USER. IT WAS NOTED THAT THE ISSUE WAS A SECOND HAND ACCOUNT FROM THE FACILITY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488168 ↗
• MalfunctionJul 14, 2021Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM COULD NOT DELETE PATIENT DATA FROM THE SOFTWARE. IT WAS NOTED THAT THE SYSTEM WAS STILL FUNCTIONAL. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168171 ↗
• MalfunctionDec 22, 2020Connection Problem; Application Program Freezes or Fails to Launch; Connection Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT WHEN THE SYSTEM WAS PLUGGED IN YESTERDAY EVENING THE AMBER LIGHT ON THE CAMERA WAS ON AND THE SOFTWARE READ " LOCALIZER NOT CONNECTED". THE UMBILICAL WAS RESEATED AND THE SYSTEM WAS REBOOT WITHOUT RESOLUTION. THE SYSTEM WAS SHUT DOWN FOR THE NIGHT AND THE ISSUE WAS RESOLVED ON BOOT UP THE NEXT MORNING. THE SYSTEM APPEARS TO BE FUNCTIONAL RIGHT NOW. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE MANUFACTURER REPRESENTATIVE (REP) REQUESTED THAT THE LOGS BE READ IMMEDIATELY TO SEE IF THE CAMERA NEEDED THE BE REPLACED. THE REP CONFIRMED THAT THE SYSTEM WAS WORKING AS INTENDED. THE CALL DROPPED AND AN EMAIL WAS SENT RECOMMENDING HOW TO CHECK THE NDI TOOLBOX TO SEE IF ANY FAULTS WERE LISTED. IF NOT, THE ERROR WAS RECOVERED AND CAMERA WILL NOT NEED TO BE REPLACED. THE REP SENT IN THE NDI TOOLBOX PICTURE AND NO FAULTS WERE LISTED AFTER THE INITIAL CALL AND REBOOT. THE SYSTEM CHECKOUT HAD THE SYSTEM WORKING AS INTENDED. NO NEED TO REPLACE THE CAMERA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055167 ↗
• MalfunctionDec 8, 2020Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT SEVERAL TIMES THE CAMERA CART POWERED DOWN ON ITS OWN AFTER BEING POWERED UP. THE SITE DIDN'T KNOW IF THE MAIN CART ALSO POWERED DOWN AT THIS TIME. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED ISSUE WAS STILL OCCURRING AFTER REPLACING THE CART TO CART CABLE. IT WAS RECOMMENDED TO THE MANUFACTURER REPRESENTATIVE (REP) TO LEAVE THE SYSTEM ON FOR A FEW HOURS TO SEE HOW LONG IT TAKES THE ISSUE TO OCCUR. THE REP WILL REPLACE THE CAMERA CART UNINTERRUPTIBLE POWER SUPPLY (UPS) TO SEE IF IT RESOLVES THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SITE CONFIRMED THAT THE OUTLET WAS FUNCTIONAL THAT THE SYSTEM WAS PLUGGED INTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968682 ↗
• MalfunctionNov 9, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE BEING PERFORMED WAS A SACROILIAC AND THORACOLUMBAR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10809352 ↗
• MalfunctionFeb 11, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAMERA ARM WAS LOOSE.

  Patient problems: No Patient Involvement

  MAUDE report 9694711 ↗
• MalfunctionFeb 11, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE CAMERA ARM WAS NOT HOLDING TENSION ON THE SYSTEM. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9694656 ↗
• MalfunctionJan 30, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE NAVIGATION SYSTEM COULD NOT RECEIVE OR PULL EXAMS OVER ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS). IT WAS REPORTED THAT THE PACS COULD NOT PING THE NAVIGATION SYSTEM AND THE SYSTEM COULD NOT QUERY PACS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9649664 ↗
• MalfunctionJan 30, 2020Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE MAIN CART OF THE NAVIGATION SYSTEM SHUT DOWN WITHOUT PROMPT FROM THE USER. AFTER ATTEMPTING TWO SEPARATE OUTLETS THE NAVIGATION SYSTEM POWERED ON. IT WAS REPORTED THAT OTHER MEDTRONIC NAVIGATION SYSTEMS FUNCTIONED AS DESIGNED. ONCE POWERED ON, THE SELF-TEST WAS PERFORMED WHERE EVERYTHING APPEARED TO BE NORMAL. THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WAS LISTED TO BE PLUGGED IN AND CHARGING. ONCE DISCONNECTED FROM THE WALL, THE NAVIGATION SYSTEM REMAINED POWERED ON. ADDITIONALLY, THE WALL PORTS THAT WERE PREVIOUSLY USED, WHERE THE ISSUE OCCURRED, COULD BE USED WITHOUT REPLICATION OF THE REPORTED ISSUE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. IT WAS NOTED THAT THE ISSUE OCCURRED DURING A PRODUCT DEMO.

  Patient problems: No Patient Involvement

  MAUDE report 9647824 ↗

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