StealthStation S8 Platform 9735670Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00643169722194), received between Feb 27, 2018 and Apr 1, 2025 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS FOUND TO BE "OFF." THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746469 ↗
• MalfunctionJan 9, 2025Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE CUSTOMER CONFIRMED THAT NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112124 ↗
• MalfunctionSep 10, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE SYSTEM WAS BOOTED THE SCREEN SAID 'LOCALIZER FAULTED' AND THERE WAS AN AMBER LIGHT ON THE CAMERA. TO TROUBLESHOOT, THE MANUFACTURER REPRESENTATIVE (REP) WENT INTO THE NETWORK DEVICE INTERFACE (NDI) TOOL BOX, A BUMP WAS DETECTED AND THE STORAGE TEMPERATURE EXCEEDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185765 ↗
• MalfunctionAug 4, 2023Connection Problem; Application Program Freezes or Fails to Launch; Connection Problem; 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 SYSTEM WAS TURNED ON BEFORE A CASE BUT THERE WAS A LOCALIZER ERROR AND THE SYSTEM WAS NOT USED IN THE CASE. AFTER CHECKING THE SYSTEM VIA NDITOOL BOX, IT WAS FOUND THAT CAMERA WAS BUMPED AND THE FOLLOWING MESSAGES WERE SHOWN: "BUMP DETECTOR BATTERY FAULT", "BUMP DETECTED. ACCURACY ASSESSMENT RECOMMENDED", AND "STORAGE TEMPERATURE EXCEEDED". THE NEXT STEP WAS TO REPLACE THE CAMERA. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459637 ↗
• MalfunctionDec 28, 2022Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD ISSUES WITH THE SYSTEM TURNING OFF UNEXPECTEDLY WHILE PLUGGED IN. THEY LEFT IT PLUGGED IN ON AND CHARGING FOR A PERIOD OF TIME, AND THEY CAME BACK TO THE CAMERA CART BEING OFF AND THE MAIN CART BEING LOGGED OUT. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060588 ↗
• InjuryJul 18, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AUTOMATED TRAJECTORY GUIDANCE UNIT BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM RECEIVED AN ERROR 0016. THE SITE RECEIVED THE ERROR 0016 AFTER THE USE OF THE ELECTRICAL SCALPEL. NO FURTHER INFORMATION WAS RECEIVED ABOUT THE PROCEDURE. THE PROCEDURE WAS ASTEREOELECTROENCEPHALOGRAPHY (SEEG). THE SURGERY WAS CANCELLED DUE TO AN ISSUE IN A DIFFERENT CASE. THERE WAS NO REPORTED IMPACT TO PATIENT. THE SITE CANCELLED THE SURGERY AFTER PLACING THE FIRST ELECTRODE AND CHECKING THAT THE ERROR WAS TOO HIGH. IT WAS CANCELLED AFTER INCISION. THE PATIENT WAS UNDER ANESTHESIA. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE SITE WAITED ABOUT AN HOUR BEFORE CANCELLING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042869 ↗
• MalfunctionMay 23, 2022Application 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 DISPLAYED "LOCALIZER DISCONNECTED" AFTER REPLACING THE BREAK OUT BOX. DISCONNECTING THE EMITTER / BREAKOUT BOX DOES NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469477 ↗
• MalfunctionJun 24, 2021Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A MULTILEVEL SPINAL FUSION. IT WAS REPORTED THAT THEY WERE UNABLE TO SEND THE IMAGING SYSTEM SCANS TO THE NAVIGATION SYSTEM. THEY TRIED REBOOTING AND TAKING ANOTHER SPIN WITH NO RESOLUTION. NO TROUBLESHOOTING METHODS WERE TAKEN AT THE TIME OF THE EVENT. THERE WAS A PROCEDURE DELAY OF FIFTEEN MINUTES AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12060301 ↗
• MalfunctionMay 18, 2021Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING THE NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING A CRANIAL BIOPSY PROCEDURE THE CAMERA CART WOULD NOT COMMUNICATE WITH THE MAIN CART. THE CAMERA CART WAS REMAINING ON THE PCIOP NETWORK SCREEN AND WOULD GO BLACK AFTER A COUPLE MINUTES. THE MANUFACTURER REPRESENTATIVE (REP) ATTEMPTED THIS WITH ANOTHER CAMERA CART AND ANOTHER INTERCONNECT CABLE. THE SYSTEM WAS PLUGGED INTO THE POWER FROM THE BOOM. TECHNICAL SERVICES (TS) RECOMMENDED REBOOTING THE SYSTEM AND MOVING IT TO A WALL OUTLET. THIS RESOLVED THE ISSUE. NO IMPACT ON PATIENT OUTCOME. PATIENT PRESENT 10 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841175 ↗
• MalfunctionApr 14, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS STATING THE LOCALIZER WAS NOT CONNECTED. THEY SWITCHED TO A DIFFERENT NAVIGATION SYSTEM FOR THE UPCOMING CASE. THERE WAS NO PATIENT IMPACT. THERE WAS A 15 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663984 ↗
• MalfunctionMar 2, 2021Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE NETWORK SWITCH WAS NOT REPLACED. THE MANUFACTURER REPRESENTATIVE STATED THAT THIS WAS AN ISOLATED INCIDENT AND THAT THERE HADN'T BEEN ANY OTHER ISSUES WITH THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399908 ↗
• MalfunctionOct 27, 2020Connection Problem; Connection Problem

  ADDITIONAL INFORMATION RECEIVED. MANUFACTURER REPRESENTATIVE REPORTED THAT AFTER TROUBLESHOOTING THE SYSTEM. IT WAS FOUND THAT WHEN SWAPPING THIS SYSTEM'S CAMERA CART TO A KNOWN WORKING MAIN CART (2ND SYSTEM), THE SYSTEM FUNCTIONED AND BOOTED WITH NO ISSUES. ON THE SELF TEST FOR THE SWAPPED SYSTEM EVERYTHING SEEMED NORMAL EXCEPT THERE WAS A RED STATUS FOR PCOIP CONNECTION TO HOST CARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10741491 ↗
• MalfunctionOct 12, 2020Environmental Compatibility Problem; Adverse Event Without Identified Device or Use Problem; Environmental Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SITE WAS IN THE MIDDLE OF A CRANIOTOMY WHEN FIRSTLY, THEY SAW A MESSAGE STATING THAT THE LOCALIZER (OPTICAL CAMERA) WAS DISCONNECTED AND THEY HAD A RED BATTERY INDICATOR WARNING. THEY DID A HARD RESET WHICH RE-CONNECTED LOCALIZER. HOWEVER, FURTHER INTO THE CASE, THIS HAPPENED ONCE MORE, THE EXACT BEHAVIOR: LOCALIZER DISCONNECTED, RED BATTERY INDICATOR. A HARD REBOOT RESOLVED THE ISSUE. THIS HAPPENED A THIRD TIME, AND THIS IS WHEN THE MAIN CART SHUT DOWN AND A FEW MINUTES LATER THE CAMERA CART SHUT DOWN. TROUBLESHOOTING WAS PERFORMED AND IT REVEALED THAT THE UNINTERRUPTED POWER SUPPLY (UPS) IS POWERING OFF RANDOMLY CAUSING THE ISSUES.

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

  MAUDE report 10663070 ↗
• MalfunctionSep 11, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE 5 NAVIGATION SPHERES THAT WERE APPLIED TO THE NEURO NAVIGATION POINTER WERE NOT BEING DETECTED BY THE NAVIGATION ARM. THE REFERENCE ARRAY SPHERES WERE ALL BEING DETECTED FROM THE SAME LOT NUMBER PACKAGES. THE FINISH ON THE SPHERES LOOKED AS THOUGH IT HAD BEEN RUBBED OFF OR WAS MUCH MORE MATTE THAN THE OTHER SPHERES. AN INSTRUMENT WAS USED TO POP THEM OFF OF THE NAVIGATION POINTER RESULTING IN SOME CUT MARKS ON THE SPHERES BUT THERE WERE NO ABRASIVE IN CONTACT WITH THE SPHERES BEFORE USE, ONLY SURGICAL GLOVES DURING APPLICATION. THERE WAS NO PERSON AFFECTED. THE DEVICE IS AVAILABLE FOR INVESTIGATION. THIS WAS DETECTED BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 10520320 ↗
• MalfunctionAug 24, 2020Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT AFTER ANESTHESIA HAD BEEN ADMINISTERED AND AFTER THE INCISION WAS MADE, DURING NAVIGATION, THERE WAS AN ALLEGED INACCURACY. WHEN THE SURGEON NOTICED AN ALLEGED INACCURACY, HE USED A FREE HAND METHOD AND DISCONTINUED NAVIGATION. THERE WAS NO DELAY TO THE PROCEDURE AND NO REPORTED IMPACT ON PATIENT OUTCOME.

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

  MAUDE report 10441459 ↗
• InjuryMay 21, 2020Computer Software Problem; Computer Software Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY WAS MINIMAL, HOWEVER WHEN DEALING WITH TRAJECTORIES THE PLACEMENT WAS OFF. IT WAS NOTED THAT THE SCREW WAS REMOVED AND REPLACED TO THE SURGEONS LIKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10081238 ↗
• MalfunctionJan 21, 2020Imprecision; Imprecision

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS SCANNED IN THE WRONG ORIENTATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9610504 ↗
• MalfunctionJan 15, 2020Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, WHEN CONNECTING THE SALINE TUBING TO THE CATHETER, THE SURGEON NOTICED THAT ONE OF THE CONNECTORS ON THE TUBING LOOKED DISCOLORED/CLOUDY AND WAS CONCERNED THAT THE TUBING WOULD LEAK. THE SITE DID NOT TEST IF THE TUBING WOULD LEAK AFTER RUNNING THE INITIAL SCANS. THE SURGEON DETERMINED THAT THE CATHETER WAS NOT IDEALLY PLACED FOR THE ABLATION; IT WAS REPORTED THAT THE CATHETER WAS NOT CENTRALLY LOCATED WITHIN THE LESION SO PROCEEDING WITH IT IN THAT POSITION WOULD NOT HAVE ABLATED ALL OF IT. IT WAS ESTIMATED THAT IT WAS 3-5 MILLIMETERS OFF. THEY WENT BACK TO THE OPERATING ROOM (OR) TO DO ANOTHER PLACEMENT AND USED ANOTHER FIBER KIT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY DUE TO THE TUBING ISSUE. IT WAS UNKNOWN IF THERE WAS ANY DELAY IN THE CASE DUE TO THE CATHETER PLACEMENT ISSUE. IT WAS REPORTED THAT IT WAS UNCLEAR WHAT WAS THE CAUSE OR CONTRIBUTING FACTORS RELATED TO THE CATHETER NOT BEING IDEALLY PLACED FOR ABLATION. IT WAS NOTED TH

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

  MAUDE report 9590689 ↗
• MalfunctionNov 26, 2019Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THEY WERE UNABLE TO TRACK THE QUADCUT IN A CASE. IN THE TRACKING VIEW, THEY SAW THE TEAL SQUARE FOR THE PATIENT TRACKER AND A BLUE CIRCLE FOR THE STRAIGHT SUCTION. HOWEVER, WHEN THEY BROUGHT IN THE QUADCUT, IT WAS IN THE TRACKING VIEW, BUT SHOWING RED. THEY LIFTED THE EMITTER AWAY FROM THE PATIENT BED AND TRACKING IN AN AREA WITH NO METAL OR MONITORS, THE SUCTION WAS STILL BLUE, BUT THE QUADCUT WAS RED. RECOMMENDED TRYING A NEW QUADCUT IF THEY WANTED TO NAVIGATE. SURGEON PROCEEDED WITHOUT NAVIGATING THE QUADCUT. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

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

  MAUDE report 9377978 ↗
• MalfunctionNov 4, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SITE WAS NOT ABLE TO REGISTER. DURING A CATHETER PLACEMENT PROCEDURE THE SURGEON WAS UNABLE TO VERIFY THE TRACER POINTER OR START A TRACE REGISTRATION BY HOLDING THE PROBE ON THE SKIN. THE SURGEON ENDED UP ABORTING THE USE OF NAVIGATION AFTER TRYING A DIFFERENT TRACER POINTER AND NON-INVASIVE PATIENT TRACKER (NIPT). A MANUFACTURER REPRESENTATIVE (REP) WAS ON SITE AND REPLICATED THE ISSUE. TECHNICAL SERVICES (TS) REQUESTED THAT THE REP CHECK THE FOOTSWITCH BEHAVIOR IN THE SOFTWARE AND DISCOVERED IT WAS SET TO REGISTRATION WITH FOOTSWITCH, NOT STATIONARY PROBE. TS ALSO INFORMED THE REP THAT THE EM CRANIAL TRACER POINTER IS AN INSTRUMENT THAT DOES NOT NEED TO BE VERIFIED IN THE SOFTWARE. THIS INFORMATION WILL BE PROVIDED TO THE SITE. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9271160 ↗
• MalfunctionOct 16, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE FOOT PEDAL WAS FUNCTIONING INTERMITTENTLY. WHILE TRACING THE FOOT PEDAL WOULD STOP WORKING. THE SITE DISCONNECTED AND THE RESEATED THE CABLE AND THEN THE TRACE WOULD START AS IF THE PEDAL WAS BEING PRESSED WHEN IT WAS NOT BEING PRESSED. THE SITE SWAPPED WITH ANOTHER FOOT PEDAL AND THE ISSUE RESOLVED. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199238 ↗
• MalfunctionSep 12, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS SATISFIED WITH THE REGISTRATION, BUT DURING THE SURGERY AND NAVIGATING TO KNOWN LANDMARKS THE SURGEON FELT INACCURATE. THE SURGEON FELT ABOUT 20 MM INACCURATE SUPERFICIALLY. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME. A REPRESENTATIVE WENT ON SITE AND PERFORMED REGISTRATION WITH A RESIN HEAD USING TOUCH AND TRACE. BOTH WERE SUCCESSFUL IN BEING ACCURATE. 1 PATIENT HAD POINT MERGE WITH ALL FIDUCIALS IN A CIRCLE ON THE BACK OF THE HEAD. 2 GREEN POINTS, 2 RED POINTS, AND 4 YELLOW POINTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9008687 ↗
• MalfunctionAug 26, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHENEVER THEY CONNECTED THE ACTIVE REFERENCE FRAME TO THE SYSTEM, THEY RECEIVE A LOCALIZER NOT CONNECTED MESSAGE IN THE SOFTWARE. WHEN THE FRAME WAS DISCONNECTED, THE FAULT CLEARED. THEY WERE ABLE TO PLUG OTHER ACTIVE INSTRUMENTS IN AND TRACK THOSE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8930717 ↗
• MalfunctionJul 22, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT WHILE LOADING EXAMS, THE SYSTEM WOULD NOT TOTALLY LOAD THE EXAMS AND THEN WOULD SHUT ITSELF OFF. THE SYSTEM WAS REBOOTED WITHOUT RESOLVE AND LANDED ON THE UBUNTU SCREEN AND WOULD NOT ADVANCE. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8811852 ↗
• MalfunctionJul 1, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED DURING SERVICING, THAT THE CAMERA CART WAS LOSING CONNECTION AND RESTARTING FROM TIME TO TIME. IT WAS ALSO NOTED BY THE REPRESENTATIVE THE CAMERA PCOIP ZERO CLIENT WAS CHANGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8748531 ↗

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