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NA 242302Recalls & reported problems

Medos International Sàrl · HD CAMERA CONTROL SYSTEM WITH INTEGRATED LIGHT SOURCE · Class 2

Quick summary

This Medos HD camera system with a built-in light source is used in arthroscopic joint surgery. Its 242 reports mostly describe the screen going dark, turning white or flickering, and some describe the image being lost during a procedure. The reports include no deaths and no injuries. 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
240
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 10886705028702), received between May 7, 2019 and Sep 9, 2026 — classified as 240 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (165 reports).

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.

Reports received per month

Nov 2023: 8 reportsDec 2023: 2 reportsJan 2024: 3 reportsFeb 2024: 2 reportsMar 2024: 4 reportsApr 2024: 3 reportsMay 2024: 1 reportsJun 2024: 3 reportsJul 2024: 5 reportsAug 2024: 5 reportsSep 2024: 2 reportsOct 2024: 2 reportsNov 2024: 1 reportsDec 2024: 3 reportsJan 2025: 7 reportsFeb 2025: 6 reportsMar 2025: 9 reportsApr 2025: 1 reportsMay 2025: 8 reportsJun 2025: 9 reportsJul 2025: 11 reportsAug 2025: 14 reportsSep 2025: 7 reportsOct 2025: 2 reportsNov 2025: 9 reportsDec 2025: 2 reportsJan 2026: 10 reportsFeb 2026: 7 reportsMar 2026: 7 reportsApr 2026: 9 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202614
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Display or Visual Feedback Problem165
  • Output Problem98
  • Intermittent Continuity19
  • Computer Software Problem17
  • Application Program Problem12
  • Use of Device Problem11
  • Electrical /Electronic Property Problem10
  • Break6

Patient problems

  • No Clinical Signs, Symptoms or Conditions213
  • No Consequences Or Impact To Patient17
  • Not Applicable7
  • No Known Impact Or Consequence To Patient2
  • No Patient Involvement2

Recent adverse event reports

The 25 most recent of 240 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 9, 2026Display or Visual Feedback Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50697343 ↗
  • MalfunctionAug 19, 2026Display or Visual Feedback Problem; Application Program Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50321438 ↗
  • MalfunctionMay 12, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT THE ALL-IN-ONE CCU+LIGHT ROW DEVICE HAD A CONSISTENT FLICKERING IMAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25147161 ↗
  • MalfunctionApr 28, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT THE ALL-IN-ONE CCU+LIGHT ROW DEVICE SETTINGS WERE THE SAME AS USUAL, BUT THE GLARE WAS SO SEVERE THAT THE IMAGE TURNED WHITE. THE SURGEON REMOVED AND REINSERTED THE CAMERA, BUT IT DID NOT IMPROVE, AND THE SURGERY CONTINUED WITH THE WHITE FIELD OF VIEW. THE SURGERY WAS REPORTEDLY COMPLETED SOMEHOW. THERE WAS A DELAY WITHIN THIRTY MINUTES REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25017646 ↗
  • MalfunctionApr 28, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING THE SURGERY, THE TOWER WAS TURNED ON AND FUNCTIONING, AND WHITE BALANCE WAS PERFORMED. THE DOCTOR PROCEEDED TO INTRODUCE THE TROCAR AND LENS INTO THE JOINT. IT WAS OBSERVED ON THE ALL-IN-ONE CCU+LIGHT ROW MONITOR THAT THE IMAGE WAS TOO BRIGHT, WHICH PREVENTED OBSERVATION OF JOINT DEFECTS IN THE WHITE AREAS. THE LENS WAS MOVED TO SOFT TISSUE, WHERE COLOR APPEARED NORMAL, BUT WHEN VIEWING CARTILAGE, A FLASH WAS OBSERVED THAT PREVENTED PERFORMANCE OF THE ARTHROSCOPY. IT WAS REPORTED THAT ADJUSTMENTS TO BRIGHTNESS AND EXPOSURE WERE ATTEMPTED WITHOUT IMPROVEMENT. THE CAMERA AND LENS ATTACHMENTS WERE DISASSEMBLED AND CLEANED WITH GAUZE, BUT THE ISSUE PERSISTED. AN ALTERNATE LIGHT SOURCE WAS REQUESTED AND CONNECTED TO RULE OUT SOURCE FAILURE; HOWEVER, THE PROBLEM REMAINED. THE TOWER WAS POWERED OFF AND RESTARTED, BUT THE ISSUE CONTINUED. IT WAS REPORTED THAT THE DOCTOR PROCEEDED TO PERFORM THE PLANNED OSTEOTOMY AND DID NOT PERFORM THE ARTHROSCOPY DUE TO INABILITY TO VISUALIZE. THE ISSUE CAUSED DISCOMFORT TO THE SPECIALIST, WHO REQUESTED URGENT EVALUATION OF THE TOWER. THE OSTEOTOMY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY OR ALTERATION IN SURGICAL TIME. IT WAS

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25016985 ↗
  • MalfunctionApr 23, 2026Output Problem; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ALL-IN-ONE CCU+LIGHT ROW DEVICE OPERATED INTERMITTENTLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24965721 ↗
  • MalfunctionApr 21, 2026Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ALL-IN-ONE CCU+LIGHT ROW DEVICE WAS HAD POOR QUALITY IMAGE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24940724 ↗
  • MalfunctionApr 15, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT THERE WAS NO PICTURE WHEN BOTH THE CAMERA AND LIGHT SOURCE WERE PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT RELATED TO THIS ISSUE. NO DELAYS WERE REPORTED. NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION HAVE BEEN MADE REGARDING THIS INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE ABOUT THE ISSUE. ALL RELEVANT DETAILS HAVE BEEN PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24889400 ↗
  • MalfunctionApr 11, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING FUNCTIONAL CHECK IT WAS FOUND THAT THE CART WAS NOT POWERING ON AND THERE WAS NO SCREEN WITH THE ALL-IN-ONE CCU+LIGHT ROW DEVICE. IT WAS REPORTED THAT THE FUSES WERE NOT WORKING. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24847430 ↗
  • MalfunctionApr 8, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE EXPOSURE WAS SET TO 50 AND BRIGHTNESS TO 30, IN LINE WITH THE USUAL SETTINGS ON THE ALL-IN-ONE CCU+LIGHT ROW DEVICE. HOWEVER, SEVERE HALATION OCCURRED, CAUSING THE IMAGE TO APPEAR ALMOST ENTIRELY WHITE. DURING THE SURGERY, ADJUSTMENTS WERE MADE BY LOWERING THE EXPOSURE TO 10 AND BRIGHTNESS TO 20. THESE CHANGES RESTORED THE FIELD OF VIEW TO NEAR-NORMAL CONDITIONS, ENABLING THE SURGICAL PROCEDURE TO PROCEED WITHOUT ANY COMPLICATIONS. DESPITE THESE IMPROVEMENTS, SOME HALATION PERSISTED. AFTER THE PROCEDURE, THE SURGEON SWITCHED THE DEVICE OFF AND ON ONCE. SUBSEQUENTLY, THE DEVICE OPERATED WITHOUT HALATION USING THE ORIGINAL EXPOSURE AND BRIGHTNESS SETTINGS OF 50 AND 30. THERE WAS NO DELAY IN THE SURGERY, AND THE PATIENT DID NOT EXPERIENCE ANY HARM. NO FURTHER INFORMATION IS AVAILABLE, AND THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24820291 ↗
  • MalfunctionApr 8, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT PRIOR TO START THE UNKNOWN SURGERY, THE MEDICAL TEAM ENCOUNTERED AN ISSUE WITH SETTING THE ALL-IN-ONE CCU+LIGHT ROW DEVICE'S WHITE BALANCE. THE SURGEON ATTEMPTED TO ADJUST THE WHITE BALANCE, BUT THE SYSTEM DISPLAYED A SPINNING ICON THAT WOULD NOT STOP, PREVENTING THE ADJUSTMENT. THE PROBLEM WAS RESOLVED BY TURNING THE DEVICE OFF AND THEN BACK ON. THIS ISSUE APPEARED TO OCCUR MORE FREQUENTLY WHEN THE DEVICE WAS USED CONTINUOUSLY FOR TWO CONSECUTIVE CASES WITHOUT BEING POWERED OFF IN BETWEEN. AS A RESULT, THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO HARM CAME TO THE PATIENT DURING THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE, AND THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24820188 ↗
  • MalfunctionApr 8, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT PRIOR TO THE SURGERY, THE SURGEON WAS UNABLE TO SET THE DEVICE'S WHITE BALANCE. DESPITE ATTEMPTS TO ADJUST THE WHITE BALANCE, THE SPINNING ICON ON THE DEVICE PERSISTED AND THE SETTING COULD NOT BE COMPLETED. THE ISSUE WAS RESOLVED ONLY AFTER THE DEVICE WAS SWITCHED OFF AND THEN BACK ON. THIS PROBLEM APPEARS TO BE MORE FREQUENT WHEN THE DEVICE IS USED CONTINUOUSLY FOR TWO CONSECUTIVE CASES WITHOUT BEING TURNED OFF IN BETWEEN. THE TECHNICAL ISSUE RESULTED IN A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. NO HARM TO THE PATIENT WAS REPORTED BECAUSE OF THE DELAY. NO FURTHER DETAILS ARE AVAILABLE REGARDING THIS CASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24816102 ↗
  • MalfunctionMar 20, 2026Computer Software Problem; Display or Visual Feedback Problem; Application Program Problem; Output Problem; Data Problem

    IT WAS REPORTED THAT THIRTY MINUTES INTO A SURGICAL PROCEDURE, THE RECORDING SUDDENLY STOPPED WHILE USING THE ALL-IN-ONE CCU+LIGHT ROW DEVICE. BECAUSE SURGERY WAS IN PROGRESS, THE SURGEON DID NOT RESTART THE SYSTEM, BUT INSTEAD RECONNECTED TO ANOTHER CCS DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. HOWEVER, TWO STILL IMAGES AND ONE VIDEO TAKEN BEFORE AND AFTER THE ERROR 004 DISPLAY WERE COMPLETELY BLACK, AND THE RECORDING COULD NOT BE SAVED. THE PRINTER WAS ABLE TO PRINT THE BLACK STILL IMAGES FROM THE CCS. PATIENT DATA HAS BEEN LOST. THERE WAS ABOUT A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24650081 ↗
  • MalfunctionMar 17, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT BEFORE AN UNSPECIFIED SURGERY, THE SURGEON WAS NOT ABLE TO SET THE WHITE BALANCE. THE SURGEON SET IT UP AS USUAL, AND WHEN HE PRESSED THE BUTTON ON THE CAMERA HEAD TO SET THE WHITE BALANCE, THE LIGHT SOURCE WENT OUT AND THE SCREEN WENT BLACK. NATURALLY, THE SURGEON WAS NOT ABLE TO SET THE WHITE BALANCE, AND THE LOADING ICON DID NOT STOP. THE SURGEON WAS ABLE TO RESTORE IT BY TURNING THE POWER OFF AND ON, AND HE USED IT NORMALLY. THE PROCEDURE WAS WITHIN 30 MINUTES OF SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24619850 ↗
  • MalfunctionMar 16, 2026Display or Visual Feedback Problem; Data Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE LIVE IMAGE TRANSMISSION OF THE ALL-IN-ONE CCU+LIGHT ROW WAS NOT WORKING. THE PATIENT REPORTING FORMAT HEADER AND FOOTER ADJUSTMENT HAD A PROBLEM. IT IS UNKNOWN IF ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24607824 ↗
  • MalfunctionMar 13, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THAT THE ALL-IN-ONE CCU+LIGHT ROW DEVICE WHEN THE WHITE BALANCE WAS RE-ADJUSTED, THE SCREEN TURNED BRIGHT RED, MAKING IT IMPOSSIBLE TO SEE ANYTHING, AND THE OPERATION WAS HALTED.. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 30 MIN. DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24591611 ↗
  • MalfunctionMar 13, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN ARTHROSCOPIC PROCEDURE, THAT THE ALL-IN-ONE CCU+LIGHT ROW DEVICE THE LIGHT SOURCE WAS NOT ABLE TO TURN ON, SO THE SURGEON COULD NOT SET THE WHITE BALANCE. THE SURGEON PLUGGED IN THE CAMERA HEAD AND LIGHT CABLE AND TRIED TO TURN ON THE LIGHT SOURCE USING THE BUTTON ON THE CAMERA HEAD, BUT NO LIGHT CAME ON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 30 MIN. SURGICAL DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24591480 ↗
  • MalfunctionMar 11, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT THE 4K C-MNT SCP,4.0,30,167,MITEK DEVICE WAS UNABLE TO SEE THOUGHT THE SCOPE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN (B)(6). ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24571046 ↗
  • MalfunctionMar 5, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE THE ALL-IN-ONE CCU+LIGHT ROW DEVICE CASE STARTED, ACCORDING TO THE WORKFLOW THE LIGHT CABLE SHOULD HAVE BEEN PLUGGED IN. THEN THE CAMERA WAS UNPLUGGED AND A DIFFERENT CAMERA WAS PLUGGED IN. AFTERWARDS THE CCS SCREEN FROZE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24518130 ↗
  • MalfunctionFeb 25, 2026Display or Visual Feedback Problem; Mechanical Problem

    IT WAS REPORTED THAT A FAILURE OF THE ALL-IN-ONE CCU+LIGHT ROW CAMERA HEAD CONNECTOR IS SUSPECTED. WHEN CONNECTING THE CAMERA HEAD, NUMEROUS HORIZONTAL LINES APPEARED ACROSS THE ENTIRE SCREEN AND THE SCREEN SOMETIMES BLACKED OUT. THE SAME SYMPTOMS WERE OBSERVED WHEN EACH OF THE THREE CAMERA HEADS AVAILABLE AT THE FACILITY WERE CONNECTED, INDICATING THE ISSUE MAY BE ON THE CAMERA SIDE THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24442538 ↗
  • MalfunctionFeb 25, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT BEFORE AN UNSPECIFIED SURGERY, THE ALL-IN-ONE CCU+LIGHT ROW WAS UNABLE TO ACHIEVE WHITE BALANCE. WHEN THE SURGEON TRY TO ADJUST THE WHITE BALANCE AFTER TURNING THE LIGHT ON, IT KEPT SPINNING AND THE SETTING COULD NOT BE DONE. TURNING THE POWER OFF AND ON AGAIN SOLVED THE PROBLEM. THERE WERE 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24441254 ↗
  • MalfunctionFeb 19, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, WHILE USING THE ALL-IN-ONE CCU+LIGHT ROW DEVICE, IT WAS OBSERVED THAT THE DEVICE WAS UNABLE TO ACHIEVE WHITE BALANCE. IT WAS REPORTED THAT THE BUTTON ON THE CAMERA HEAD WAS PRESSED TO ADJUST THE WHITE BALANCE, BUT THE DEVICE WOULD NOT MOVE BEYOND THE SPINNING ICON, AND THE WHITE BALANCE COULD NOT BE ACHIEVED. AFTER CYCLING THE POWER AND TRYING AGAIN, THE WHITE BALANCE WAS SUCCESSFULLY SET. IT WAS REPORTED THAT THERE WAS A 30-MINUTE SURGICAL DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24394020 ↗
  • MalfunctionFeb 17, 2026Display or Visual Feedback Problem; Application Program Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE ALL-IN-ONE CCU+LIGHT ROW DEVICE REBOOTED, THE LIGHT WAS REDUCED, AND IT SUBSEQUENTLY DISPLAYED "004 ERROR". IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JANUARY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24365522 ↗
  • MalfunctionFeb 13, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT BEFORE THE SURGERY, THE ALL-IN-ONE CCU+LIGHT ROW CAMERA WAS SET UP AS NORMAL AND THE BUTTON ON THE CAMERA HEAD WAS PRESSED TO SET THE WHITE BALANCE BUT THE SPINNING ICON NEVER STOPPED AND THE WHITE BALANCE COULD NOT BE SET. AFTER TURNING THE POWER OFF AND RESTARTING, THE WHITE BALANCE WAS ABLE TO BE SET. THERE WAS 30 MINUTES SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24335075 ↗
  • MalfunctionFeb 13, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE ALL-IN-ONE CCU+LIGHT ROW WAS SET UP BUT THE IMAGE HAD A GREENISH TINT, WHICH WAS UNUSUAL. WHEN THE LIGHT SOURCE WAS TURNED ON, THE SCREEN TURNED FROM PALE YELLOW TO SOLID WHITE, AND EVEN WHEN USED, THE SURGEON WAS UNABLE TO SEE THE SUBJECT THAT WAS SUPPOSED TO BE DEPICTED ON THE SCREEN AT ALL. THERE WAS 30 MINUTE SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24331560 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.