Fusion™ ENT Image Guidance System 9733560XOMRRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00613994594235), received between Sep 29, 2016 and Nov 1, 2022 — classified as 66 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (18 reports).

28 other recalls cover devices cleared under the same FDA submission (K001284); 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THIS SYSTEM WAS BOOTING TO A MESSAGE OF LOCALIZER NOT CONNECTED. REBOOTING THE SYSTEM HAD NO CHANGE. THE SITE ALSO HAD A DIFFERENT NAVIGATION SYSTEM ON SITE SO THEY SWITCHED TO THAT SYSTEM FOR THIS PROCEDURE. PATIENT WAS UNDER FOR ABOUT AN HOUR BUT TOTAL DELAY TO THE PROCEDURE WAS ABOUT 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709638 ↗
• MalfunctionAug 25, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAD A DAMAGED POWER CABLE. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15296131 ↗
• MalfunctionJun 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 WAS EXPERIENCING LOW PERFORMANCE. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787579 ↗
• MalfunctionDec 13, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING AN ETHMOIDECTOMY. IT WAS REPORTED THAT THE ELECTROMAGNETIC LOCALIZATION SYSTEM WAS NOT COMMUNICATING WITH THE NAVIGATION SYSTEM. TECHNICAL SERVICES HAD THEM OPEN THE EMITTER INTERFACE AND FOUND FAULT CODES ON ALL FOUR POWER SUPPLIES. THE SURGEON ABORTED NAVIGATION. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12988623 ↗
• MalfunctionMay 11, 2021Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING THE NAVIGATION SYSTEM. IT WAS REPORTED THAT DURING AN OUTSIDE PROCEDURE THERE WAS ISSUES TRACKING THE INSTRUMENT TRACKER. THE MANUFACTURER REPRESENTATIVE (REP) SWAPPED INSTRUMENT TRACKERS AND THE ISSUE DID NOT RESOLVE. THE REP ALSO SWAPPED THE INSTRUMENTS PORTS AND IT DID NOT RESOLVE THE PROBLEM. THE REP NOTICED A DELAY IN THE SYSTEM PICKING UP WHAT WAS PLUGGED INTO AXEM PORT. THE EM INTERFACE WAS NORMAL. UPON RETURNING TO THE APPLICATION, AXIEM/EM BOX WAS SHOWING DISCONNECTED. THEY NOTICED CERTAIN AREAS IN THE TRACKING VOLUME DID NOT TRACK THE INSTRUMENT. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805583 ↗
• MalfunctionApr 6, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE. IT WAS REPORTED THAT DURING A PROCEDURE THE SYSTEM WAS UNRESPONSIVE. THE SYSTEM HAD TO BE HARD SHUT DOWN. SYSTEM WORKED AS INTENDED AFTER THE REBOOT. PATIENT PRESENT WITH NO PATIENT IMPACT AND A TWO MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619716 ↗
• MalfunctionFeb 25, 2021Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE MOUSE HAD NOT BEEN WORKING. THIS WAS REPORTED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVED. IT WAS REPORTED THAT THERE HAS BEEN NO ISSUES WITH THE MOUSE SINCE INITIAL REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381176 ↗
• MalfunctionFeb 18, 2021Computer Software Problem; Computer Software Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT WHENEVER THE SITE TRIED TO OPEN DICOM Q/R, THEY WOULD SEE A BLACK SCREEN THAT SAYS "LOADING" FOR APPROXIMATELY 5 MINUTES AND THEN SEE "FAILURE IN SR MANAGER" STATING THAT IT WAS UNRECOVERABLE TO WHICH THE SYSTEM WOULD REBOOT. TROUBLESHOOTING WAS PERFORMED. TECHNICAL SERVICES RECOMMENDED SITE TRIED TO ACCESS THE ENT SOFTWARE AND WAS ABLE TO WITH NO ISSUES. THEN EXITED AND TRIED TO ENTER DICOM Q/R WITH NO RESOLVE. NO PATIENT PRESENT. IT WAS REPORTED THAT THE ISSUE WAS CAUSE BY CORRUPTED DICOM SOFTWARE. THE ISSUE HAS BEEN RESOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346117 ↗
• MalfunctionDec 22, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION FROM A MANUFACTURER REPRESENTATIVE REGARDING A NAVIGATION SYSTEM DURING A FUNCTIONAL ENDOSCOPIC SPINAL SURGERY. IT WAS REPORTED THAT WHEN ATTEMPTING TO NAVIGATE A THREE INCH LINE WENT THROUGH THE SCREEN AND MOUSE WENT DEAD, NO CURSOR, NO LIGHT ON THE MOUSE, THEN "NO VIDEO" WOULD DISPLAY. THEY WOULD HAVE TO REBOOT TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11059847 ↗
• MalfunctionDec 10, 2020Failure to Shut Off; Failure to Shut Off

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT WHILE SHUTTING DOWN THE SYSTEM THE MONITOR WENT TO A BLACK SCREEN AND THE POWER LIGHT WAS YELLOW. THE SYSTEM WAS SHUTOFF, RE-BOOTED, AND WAS ABLE TO SHUT DOWN NORMALLY. NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10983553 ↗
• MalfunctionNov 17, 2020Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THE SYSTEM POWERED OFF WHILE PLUGGED INTO WALL POWER. A MANUFACTURER REPRESENTATIVE CALLED IN TO CLARIFY WHAT HAD HAPPENED WAS THE SYSTEM HAD EXITED THE EAR, NOSE & THROAT (ENT) SOFTWARE AND WENT BACK INTO THE APPLICATION LAUNCH SCREEN. THIS ISSUE WAS NOTED OUTSIDE OF A PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING AN UNINSTALL/REINSTALL OF THE SOFTWARE APPEARED TO RESOLVE THE LOGGING OUT BEHAVIOR, BUT THEN WHEN ATTEMPTING TO RELOAD PATIENTS THAT HAD BEEN DELETED DURING THE REINSTALL, THE DISC SAID IT LOADED 100% BUT THE PATIENT DID NOT APPEAR IN THE LIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10856423 ↗
• MalfunctionAug 31, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS DUE TO REINSTALLING THE SOFTWARE.

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

  MAUDE report 10471407 ↗
• MalfunctionAug 3, 2020Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE NAVIGATION SYSTEM COULD NOT LOAD PATIENT EXAMS VIA CD. IT WAS REPORTED THAT THE INDICATOR LIGHT WOULD ILLUMINATE AFTER INSERTING THE DISC, HOWEVER THE LIGHT WOULD TURN OFF AND NOTHING APPEARED ON THE MONITOR OF THE NAVIGATION SYSTEM. IT WAS REPORTED THAT THE ISSUE RECURRED WITH MULTIPLE KNOWN GOOD DISCS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 10357019 ↗
• MalfunctionJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY VERIFYING INSTRUMENTS AND REGISTERING THE PATIENT. IT IS UNKNOWN WHAT THE GEOMETRY ERROR ON THE PATIENT TRACKER WAS, AS THEY CALLED HIM TO REPORT AFTER THE CONCLUSION OF THE PROCEDURE. THE SITE WAS ABLE TO VERIFY AND REGISTER TO COMPLETE THE PROCEDURE. THE MANUFACTURER REPRESENTATIVE WAS ON SITE TO CHECK THE SYSTEM AND WAS ABLE TO VERIFY THE STRAIGHT SUCTION WITH A DISTANCE-TO-DIVOT VALUE OF 1.9MM, WITHOUT ISSUE, ALTHOUGH THE TRACKING FIELD APPEARED TO BE CLOSER TO THE EMITTER THAN NORMAL WHILE HE HAD THE EMITTER MOUNTED ON THE FUSION RAIL. HE STATED THAT THERE ISA VISIBLE CRACK ON THE EMITTER. THERE WAS A REPORTED DELAY OF THERE WAS A 30-40 MINUTES. THERE IS NO KNOWN IMPACT ON PATIENT OUTCOME. IT WAS REPORTED THAT INSTRUMENT MANIPULATION WAS DONE. THE INSTRUMENT WAS PLACED IN VARIOUS POSITIONS TO ACHIEVE VERIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10247168 ↗
• MalfunctionDec 26, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  2020-JAN-15: NEW INFORMATION RECEIVED: PATIENT INFORMATION NOT AVAILABLE DUE TO COMPUTER IN SYSTEM WAS CHANGED. THE SITE WAS NOT ABLE TO FIND INFORMATION ON PAST SCHEDULE. SURGEON'S NAME PROVIDED. NAVIGATION WAS ABORTED DUE TO SYSTEM FREEZING UP TWICE. CASE WAS NEARING COMPLETION WHEN THIS OCCURRED AND DOCTOR FELT COMFORTABLE TO FINISH PROCEDURE WITHOUT NAVIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9520048 ↗
• MalfunctionNov 13, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS LOADING AN EXAM AS AN UNSTRUCTURED DICOM AND IT TOOK AN EXTENDED PERIOD OF TIME. WHEN THE SCAN DID LOAD THE INFERIOR PORTION OF THE SCAN DID NOT LOAD FROM THE NASAL BONE DOWN. THE SITE WAS ABLE TO LOAD THE SCAN SUCCESSFULLY ON THE A DIFFERENT NAVIGATION SYSTEM.

  Patient problems: No Patient Involvement

  MAUDE report 9317812 ↗
• MalfunctionSep 18, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO REGISTER THE PATIENT. THE TRACKER CAD MODEL WAS SHOWING AS THE OLD STYLE TRACKER AND THEN DISAPPEARED. THE TRACE POINTS WERE COLLECTING OFF THE 3D MODEL. THE SITE ABORTED NAVIGATION. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9081718 ↗
• MalfunctionAug 27, 2019Environmental Compatibility Problem; Environmental Compatibility Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WITH THEIR NAVIGATION SYSTEM BEING ABLE TO TURN ON. IT WAS ALSO STATED THAT THE SYSTEM WOULD SOMETIMES POWER DOWN ON THEM OUT OF NO WHERE. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8934719 ↗
• MalfunctionJul 31, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE MANUFACTURER REPRESENTATIVE (REP) WAS ABLE TO GET DISCS TO LOAD ON THE FUSION COMPACT BUT THE SAME DISCS WOULD NOT LOAD ON THE FUSION. THE REP RESEATED THE DISC DRIVE WHICH RESOLVED THE ISSUE. TECHNICAL SERVICES SHIPPED A DVD DRIVE AS A PRECAUTION DUE TO THE INDETERMINACY OF THE ISSUE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8848146 ↗
• MalfunctionJul 15, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES TRACKING INSTRUMENTS. A MEDTRONIC REPRESENTATIVE (REP) WAS ON SITE AND NOTED THAT THE EMITTER PLACEMENT WAS NOT OPTIMAL. THE EMITTER WAS ABOUT 2 FEET AWAY FROM THE PATIENT. THE REP SUGGESTED MOVING THE EMITTER. AFTER THE EMITTER WAS MOVED, THE ISSUE WAS RESOLVED. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8791923 ↗
• MalfunctionJun 25, 2019Mechanical Problem; Human-Device Interface Problem; Mechanical Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY. IT WAS REPORTED THAT DURING THE CLINICAL CASE, THE PATIENT EXAM DISC WOULD NOT LOAD. USING THE STRUCTURED OPTION, IT WOULD GIVE THE PATIENT'S NAME, BUT WHEN SELECTING IT TO LOAD IT PROVIDED AN ERROR STATING IT WAS UNABLE TO READ THE DISC. WHEN LOADING WITH ANY OF THE UNSTRUCTURED OPTIONS, THE SYSTEM DID NOTHING, EVEN AFTER WAITING SEVERAL MINUTES. TECHNICAL SERVICES (TS) HAD THE SITE REPRESENTATIVE REBOOT THE SYSTEM AND CHECK THE FREE SPACE ON THE SYSTEM, WHICH SHOWED 32% FREE SPACE. THE SITE REP DELETED EXAMS UNTIL THE SYSTEM WAS AT 40% FREE SPACE. SELECTING UNSTRUCTURED ALTERNATE MODULE GENERATED THE MESSAGE OF "UNABLE TO INTERPRET HEADER DATA". THE SITE REP WILL HAVE A NEW DISC BURNED WITH UNCOMPRESSED DICOM. THE MEDTRONIC REPRESENTATIVE REPORTED THAT THE SURGEON DID NOT INFORM HIM OF ANY OTHER ISSUES IN THE CASE AFTER REBURNING, AND THE SITE HAS HAD NO FURTHER ISSUES. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731137 ↗
• MalfunctionJun 24, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), AN IMPRECISION WAS OBSERVED. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726797 ↗
• MalfunctionJun 14, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED AFTER VERIFYING A STRAIGHT SUCTION, IT WOULD LOSE ITS VERIFICATION AND REQUEST THE INSTRUMENT BE VERIFIED AGAIN. AFTER VERIFYING A SECOND TIME IT WOULD TRACK BUT ONLY IN THE LOWER 2/3RDS OF THE APPROXIMATED EMITTER VOLUME. THE INSTRUMENT TRACKER WAS NOT SWITCHED OR MOVED AT ANY POINT. TO VERIFY THE INSTRUMENT, THEY HAD TO TILT THE SUCTION DOWN AND AWAY FROM THE BASE OF THE DIVOT; DEVIATING FROM THE STANDARD VERIFICATION TECHNIQUE GOING STRAIGHT IN TOWARDS THE BASE OF THE DIVOT. AFTER GETTING A VERIFICATION TO STICK AND USING THE INSTRUMENT FOR A FEW MOMENTS AND SWITCHING TO THE SHAVER THEN BACK TO THE SUCTION, THE VERIFICATION WAS AGAIN LOST. THERE WAS A 10-MINUTE DELAY TO THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8701295 ↗
• MalfunctionJun 13, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO PASS TRACER REGISTRATION. REPRESENTATIVE STATED THAT 3D MODEL LOOKED GOOD, THAT ONLY THE EARS AND BACK OF THE HEAD WERE CUT OFF FROM THE SCAN. THE SCAN WAS DONE AT THE END OF JUNE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF NAVIGATION. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO KNOWN IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8698531 ↗
• MalfunctionJun 12, 2019Display or Visual Feedback Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM WAS EXPERIENCING ISSUES WITH THE MONITOR FREEZING. A MANUFACTURER REPRESENTATIVE WENT ON-SITE AND CHECKED OUT THE SYSTEM. IT WAS NOTED THAT WHEN TURNING ON THE SYSTEM, IT WORKED FINE. THE REPRESENTATIVE WENT INTO THE PATIENT INFORMATION AND THAT CHECKED OUT. WHEN THEY WENT BACK IN THE SOFTWARE, THEY NOTED THAT THE MOUSE STOPPED WORKING, THE SCREEN FROZE, AND THE MONITOR WENT BLANK STATING "NO VIDEO INPUT". THE REPRESENTATIVE TURNED THE SYSTEM ON AND OFF AGAIN AND THE SYSTEM BOOTED UP AFTER A BRIEF MOMENT. IT WAS NOTED THAT TROUBLESHOOTING INCLUDED RE-SEATING THE CABLES, CHECKING THE CABLES FOR DAMAGE, AND RESTARTING THE SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8693754 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001284. One submission often covers many models, so check the product and lot details in each record.

• Z-2317-2016 · Jul 18, 2016 · Terminated
  Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation Syste
• Z-2319-2016 · Jul 18, 2016 · Terminated
  MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation Sys
• Z-1598-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733066, BIOPSY, INT
• Z-1600-2014 · Apr 24, 2014 · Terminated
  TUMOR RESECTION KIT 9733607 NON-INVASIVE
• Z-1592-2014 · Apr 24, 2014 · Terminated
  PIN, 9733235, 100MM, STERILE, PERC REF
• Z-1578-2014 · Apr 24, 2014 · Terminated
  BAG 9732315 MOUSE STERILE 15 PK
• Z-1579-2014 · Apr 24, 2014 · Terminated
  BIOPSY NEEDLE KIT, 9733068, PASSIVE
• Z-1580-2014 · Apr 24, 2014 · Terminated
  BIT 9733516 2.9mm DRILL STERILE
• Z-1582-2014 · Apr 24, 2014 · Terminated
  DISP 9730951 STRL SPHERE, 5PK INSERT
• Z-1597-2014 · Apr 24, 2014 · Terminated
  TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
• Z-1594-2014 · Apr 24, 2014 · Terminated
  SHUNT KIT 9733605 NON-INVASIVE
• Z-1586-2014 · Apr 24, 2014 · Terminated
  INSTRUMENT TRACKER 9733533XOM ENT 1PK
• Z-1587-2014 · Apr 24, 2014 · Terminated
  KIT, 9731427, THORACIC TACTILE PROBES
• Z-1591-2014 · Apr 24, 2014 · Terminated
  PATIENT TRACKER 9733534XOM ENT 1PK
• Z-1589-2014 · Apr 24, 2014 · Terminated
  PACK 9731975 TUMOR RESECTION AXIEM CR

…and 13 more.