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Fusion™ ENT Image Guidance System 9733560 (UDI 00643169504394)Recalls & reported problems

Medtronic Navigation, Inc. · SYSTEM 9733560 FUSION EM · Class 2

All models of Fusion ENT Image Guidance System (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Medtronic Fusion ENT image guidance system helps surgeons track instruments against scans during ear, nose and throat surgery. Its 457 reports mostly describe the software freezing or failing to launch, screens going black, and tracking that is imprecise. The reports include no deaths and 10 injuries, and fell to 2 in the last 12 months from 22 in the 12 months before. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
458
Deaths reported
0
Injuries reported
10
Recalls naming it
0

Summary

The FDA's MAUDE database contains 458 adverse event reports that list this exact device (DI 00643169504394), received between Oct 14, 2016 and Sep 10, 2026 — classified as 10 injuries, 448 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (89 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 3 reportsFeb 2024: 3 reportsMar 2024: 2 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 3 reportsAug 2024: 11 reportsSep 2024: 12 reportsOct 2024: 7 reportsNov 2024: 6 reportsDec 2024: 2 reportsJan 2025: 6 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202612
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Application Program Freezes or Fails to Launch89
  • Human-Device Interface Problem81
  • Imprecision66
  • Communication or Transmission Problem52
  • Display or Visual Feedback Problem50
  • Mechanical Problem50
  • Device Sensing Problem37
  • Device Operates Differently Than Expected36

Patient problems

  • No Clinical Signs, Symptoms or Conditions187
  • No Patient Involvement124
  • No Known Impact Or Consequence To Patient105
  • No Consequences Or Impact To Patient42
  • Cerebrospinal Fluid Leakage6
  • Iatrogenic Source4
  • Blood Loss1
  • Headache1

Recent adverse event reports

The 25 most recent of 458 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 10, 2026Communication or Transmission Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50721602 ↗
  • MalfunctionFeb 2, 2026Application Program Problem; Communication or Transmission Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN LOADING A PATIENT DISC, THE MANUFACTURER REPRESENTATIVE (REP) RECEIVED A DISC FORMAT ERROR. TROUBLESHOOTING STEPS WERE PERFORMED. THE REP HAD A NEW DISC BURNED WHICH HAD THE SAME FORMAT ERROR. THE REP STATED ONE DISC WAS UNCOMPRESSED DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) AND ONE WAS NOT BUT BOTH HAD THE SAME ERROR. THE EXAM SHOWED 0 SLICES, 0 THICKNESS, ETC. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24235801 ↗
  • MalfunctionDec 23, 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 SCREEN WAS BLACK. THEY WERE ABLE TO TURN ON THE SYSTEM, BUT AS SOON AS THE UNIT BOOTED UP, THE SCREEN STAYED BLACK. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23877089 ↗
  • MalfunctionJul 15, 2025Display 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 THERE WAS AN INTERMITTENT SYNC MESSAGE AND THEN THE SCREEN WOULD GO BLACK. THE POWER LIGHT EMITTING DIODE (LED) STAYED ILLUMINATED. IT WAS NOTED THAT REBOOTING DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22507040 ↗
  • MalfunctionJul 9, 2025Communication or Transmission Problem; Delayed Program or Algorithm Execution; Communication or Transmission Problem; Delayed Program or Algorithm Execution

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM HAS BEEN TAKING LONGER TO LOAD EXAMS AND THAT THE SOFTWARE "APPEARED SLOWER THAN USUAL". THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22462336 ↗
  • MalfunctionJun 16, 2025Mechanical Problem; Mechanical Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTROMAGNETIC LOCALIZATION SYSTEM/EMITTER (AXIEM¿) INTEGRATED 4-PORT SYSTEM WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22214461 ↗
  • MalfunctionJun 12, 2025Communication or Transmission Problem; Delayed Program or Algorithm Execution; Communication or Transmission Problem; Delayed Program or Algorithm Execution

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN CONTEXT. IT WAS REPORTED THAT THE SYSTEM WAS SLOW UPDATING RESULTS OF TESTS. PATIENT PRESENCE UNKNOWN. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE OCCURRED BEFORE PLANNING THE SURGERY WITH NO PATIENT PRESENT. THE SYSTEM HAD PROBLEMS READING PATIENT IMAGES FROM THE DISK. THE SITE WAS PREPARING FOR A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE AND IT WAS ABLE TO BE COMPLETED. THERE WAS NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22195363 ↗
  • MalfunctionApr 24, 2025Device Sensing Problem; Device Sensing Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE REPORTED ISSUE WAS INTERMITTENT TRACKING OF INSTRUMENTS. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21902773 ↗
  • MalfunctionMar 26, 2025Mechanical Problem; Mechanical Problem

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE. IT WAS REPORTED THAT IN REGARDS TO THE SURGICAL PROCEDURE, THE PROCEDURE WAS NOT ABORTED AND IT WAS CARRIED OUT WITH NAVIGATIONAL GUIDANCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21699624 ↗
  • MalfunctionMar 21, 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 WHENEVER THE SYSTEM TURNED ON THE UNIT PROVIDES INDICATION THAT IT WAS RECEIVING POWER FOR EXAMPLE THE SYSTEM FAN WAS ON, BUT THE MONITOR REMAINED BLACK. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21662597 ↗
  • MalfunctionFeb 7, 2025Device Sensing Problem; Human-Device Interface Problem; Device Sensing Problem; Human-Device Interface Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). IT WAS REPORTED THAT THE EMITTER FIELD WAS "VERY SMALL" AND THE INSTRUMENTS WERE NOT TRACKING AS EXPECTED. THE REPRESENTATIVE ON SITE REPORTED THAT REGISTRATION WAS COMPLETED SUCCESSFULLY AND ACCURACY WAS VERIFIED. THEN MID-WAY THROUGH THE PROCEDURE WHEN SWITCHING TO THE 70 DEGREE CURVED SUCTION INSTRUMENT, THE REP REPORTED THAT THE SURGEON TOUCHED APPX. 4 CM AWAY FROM THE PATIENT TRACKER AND THE SYSTEM REGISTERED THAT THE BACK BUTTON HAD BEEN TOUCHED "SEVERAL TIMES". THE REP REPORTED THAT THIS CAUSED THE REGISTRATION TO BE "ERASED" AND THE SURGEON HAD TO RE-REGISTER THE PATIENT. THE PROCEDURE CONTINUED WITHOUT ANOTHER INCIDENT OF THIS NATURE, HOWEVER THE REP REPORTED THAT THROUGHOUT THE ENTIRE PROCEDURE THE EMITTER FIELD REMAINED "VERY SMALL". THERE WAS NO IMPACT ON PATIENT OUTCOME. IT WAS NOTED THAT THERE WERE NO EXTERIOR METAL IN THE FIELD. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS LESS THAN 1 HOUR DELAY IN THE SURGICAL PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21333694 ↗
  • MalfunctionJan 30, 2025Display or Visual Feedback Problem; Application Program Problem; Power Problem; Display or Visual Feedback Problem; Application Program Problem; Power Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON BOOTUP, THE SYSTEM MONITOR REMAINED ON A BLACK SCREEN. THE SITE NOTED THAT THE SYSTEM FANS DID NOT APPEAR TO BE RUNNING, AND THE ELECTROMAGNETIC NAVIGATION INTERFACE UNIT (AXIEM) BOX DISPLAYED ERROR CODE 8. SITE NOTED THAT THE SYSTEM'S POWER SWITCH WAS ILLUMINATED AND THE MONITOR HAD AN ORANGE BUTTON ILLUMINATED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21275570 ↗
  • MalfunctionJan 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 THE SYSTEM WAS HAVING TROUBLE PULLING IMAGES FROM PICTURE ARCHIVING AND COMMUNICATION SYSTEM(PACS). WHEN SEARCHING FOR A PATIENT VIA MEDICAL RECORD NUMBER (MRN) NUMBER, THE SEARCH QUERY DIDN'T BRING UP ANY RESULTS. TROUBLESHOOTING WAS PERFORMED; THE SITE CALLED THE INFORMATION TECHNOLOGY (IT) DEPARTMENT TO OBTAIN PACS IP ADDRESS. TECHNICAL SERVICES(TS) WALKED SITE THROUGH OBTAINING SYSTEM IP ADDRESS AND MAC ADDRESS. AFTER TROUBLESHOOTING WITH IT, IT WAS DISCOVERED THAT THE PATIENT'S MRN NUMBER WAS ENTERED INCORRECTLY, AND THE SYSTEM PERFORMED A QUERY BY LAST NAME WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21208091 ↗
  • MalfunctionJan 15, 2025Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback 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 THE SYSTEM BECAME UNRESPONSIVE AFTER LOADING IMAGES FROM PACS (PICTURE ARCHIVING AND COMMUNICATION SYSTEM). THE IMAGE DID SHOW UP IN THE LIST OF IMAGES, BUT WHEN SELECTED, THE SYSTEM DISPLAYED THE BLUE "MEDTRONIC FUSION ENT NAVIGATION" SCREEN AND BECAME UNRESPONSIVE. A HARD REBOOT WAS PERFORMED, WHICH RESOLVED THE ISSUE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21160195 ↗
  • MalfunctionJan 7, 2025Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

    THE SYSTEM FAILED TO BOOT. THE PROBABLE CAUSE WAS LIKELY A BAD COMPUTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21096024 ↗
  • MalfunctionJan 2, 2025Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE POWER SWITCH WAS FLIPPED, THE SYSTEM DID NOT APPEAR TO TURN ON. THE MONITOR REMAINED ON A BLACK SCREEN, NONE OF THE SYSTEM FANS COULD BE HEARD, BUT THE GREEN LIGHT ON THE POWER SWITCH WAS ILLUMINATED. NO PATIENT WAS PRESENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21060528 ↗
  • MalfunctionJan 2, 2025Display or Visual Feedback Problem; Application Program Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; 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 WHILE PERFORMING PLANNED MAINTENANCE (PM) ON THE SYSTEM, THE MONITOR BOOTED TO A BLACK SCREEN WITH A MESSAGE THAT READ "NO SYNC." THE MANUFACTURER REPRESENTATIVE (REP) RESET THE COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY AND SYSTEM BOOTED AS EXPECTED. THE PROBABLE CAUSE WAS THE CMOS BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21057833 ↗
  • MalfunctionDec 4, 2024Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT UPON BOOTUP, THE SYSTEM DISPLAYED A BLACK SCREEN, AND THE POWER SWITCH WAS ILLUMINATED WITH AN AUDIBLE FAN NOISE. TROUBLESHOOTING WAS PERFORMED, AND THE COMPLEMENTARY METAL-OXIDE-SEMICONDUCTOR (CMOS) WAS RESET. THE SYSTEM POWERED UP SUCCESSFULLY AND IT WAS NOTED THAT THE DATE AND TIME WERE INCORRECT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20849623 ↗
  • MalfunctionDec 2, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback 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 DURING A PLANNED MAINTENANCE (PM) THE MANUFACTURER REPRESENTATIVE (REP) FOUND THE SYSTEM BOOTED UP TO A BLACK SCREEN. THE REP RESET THE COMPLEMENTARY METAL-OXIDE SEMICONDUCTOR (CMOS) BATTERY AND THE SYSTEM BOOTED UP AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20823094 ↗
  • MalfunctionNov 27, 2024Use of Device Problem; Application Program Problem; Application Program Freezes or Fails to Launch; Use of Device Problem; 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 UPON BOOTUP, THE SYSTEM DISPLAYED "NO INPUT DETECTED," AND NONE OF THE SYSTEM'S FANS APPEARED TO TURN ON. THE ISSUE WAS IDENTIFIED AS POTENTIALLY RELATED TO THE COMPLEMENTARY METAL-OXIDE-SEMICONDUCTOR (CMOS) BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20797382 ↗
  • MalfunctionNov 18, 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 SYSTEM WAS SAYING "NO SYNC". THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20708044 ↗
  • MalfunctionNov 14, 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 WHEN INSERTING DISCS INTO THE COMPACT DISC (CD) DRIVE, THE EXAM QUALITY WAS VERY POOR AND SOMETIMES CAME ACROSS AS A "GRAY/WHITE BOX." DOWNLOADING VIA THE NETWORK, CAUSED NO ISSUES WITH THE EXAM AND QUALITY WAS GREAT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20683392 ↗
  • MalfunctionNov 12, 2024Device Sensing Problem; Device Sensing Problem

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SITE HAD INTERMITTENT TRACKING WITH A 4.3MM QUAD CUT (1884380EM) INSTRUMENT DURING A SINUS SURGERY. PATIENT TRACKER WAS TRACKING WITHOUT ISSUE. TECHNICAL SERVICES (TS) HAD THE SITE CHECK FOR METAL INTERFERENCE IN THE FIELD, AND THE SITE NOTED THAT THEY WERE OPERATING ON A METAL TABLE AND THERE WAS AN IV (INTRAVENOUS) TREE NEARBY. TS HAD THE SITE REPOSITION THE EM (ELECTROMAGNETIC) EMITTER SEVERAL TIMES TO TRY TO RESOLVE THE ISSUE. TS NOTED THAT THE INSTRUMENT TRACKED WITHOUT ISSUE WITHIN THE SINUS CAVITY BUT WAS NOT TRACKING WHEN THE INSTRUMENT WAS TOUCHING THE TIP OF THE NOSE. TS THEN HAD THE SITE PLUG THE INSTRUMENT INTO A NEW PORT WITH NO IMPROVEMENT. THE SURGEON WAS WRAPPING UP THE SURGICAL CASE AT TIME OF THE CALL, AND NO ADDITIONAL TROUBLESHOOTING WAS COMPLETED. THERE WAS NO REPORTED IMPACT TO PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY TO THE PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20667397 ↗
  • MalfunctionNov 5, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback 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 THE SCREEN NO LONGER RECEIVED A SIGNAL. THERE WAS NO VIDEO AND A BLACK SCREEN. THE PROBABLE CAUSE WAS SUSPECTED TO LIKELY BE THE COMPUTER OR COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20606228 ↗
  • MalfunctionNov 4, 2024Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback 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  DURING SYSTEM BOOT-UP, THE MONITOR CHANGED TO "NO SYNC" AND A BLACK SCREEN. THE COMPUTER CABLE CONNECTOR WAS CHECKED AND HARDWARE CLEANING PERFORMED AND THE SYSTEM WAS ABLE TO BOOT-UP NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20602758 ↗

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-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-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-1587-2014 · Apr 24, 2014 · Terminated
    KIT, 9731427, THORACIC TACTILE PROBES
  • Z-1597-2014 · Apr 24, 2014 · Terminated
    TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
  • Z-1598-2014 · Apr 24, 2014 · Terminated
    TRAJ GUIDE KIT, 9733066, BIOPSY, INT
  • Z-1588-2014 · Apr 24, 2014 · Terminated
    MOUSE 9732721 STERILE O-ARM 10PK
  • Z-1589-2014 · Apr 24, 2014 · Terminated
    PACK 9731975 TUMOR RESECTION AXIEM CR
  • Z-1591-2014 · Apr 24, 2014 · Terminated
    PATIENT TRACKER 9733534XOM ENT 1PK
  • Z-1584-2014 · Apr 24, 2014 · Terminated
    ENT PRGM 9734636 ADD FUSION NAV AxiEM
  • Z-1602-2014 · Apr 24, 2014 · Terminated
    UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
  • Z-1594-2014 · Apr 24, 2014 · Terminated
    SHUNT KIT 9733605 NON-INVASIVE
  • Z-1585-2014 · Apr 24, 2014 · Terminated
    INST 9731132 KIT CR REF FRAME DRIVER 5PK
  • Z-1600-2014 · Apr 24, 2014 · Terminated
    TUMOR RESECTION KIT 9733607 NON-INVASIVE
  • Z-1579-2014 · Apr 24, 2014 · Terminated
    BIOPSY NEEDLE KIT, 9733068, PASSIVE
  • Z-1586-2014 · Apr 24, 2014 · Terminated
    INSTRUMENT TRACKER 9733533XOM ENT 1PK

…and 13 more.

Other Neurological stereotaxic Instrument devices

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Sources and updates

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