NA 8404ZXRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04048551432778), received between Apr 24, 2025 and May 22, 2026 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 22, 2026Erratic or Intermittent Display

  THE CUSTOMER REPORTED THAT DEVICE IS FLICKERING INTERMITTENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262104 ↗
• MalfunctionMay 6, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE DEVICE INTERMITTENTLY SHUT DOWN AFTER START-UP DURING USE, SHOWED TEMPORARY FUNCTIONALITY, BUT REPEATED THE SAME FAILURE LATER. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097156 ↗
• MalfunctionMar 31, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT WHEN STARTING THE C-MAC MONITOR, THE MONITOR GOT STUCK IN THE START UP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749234 ↗
• MalfunctionMar 10, 2026Display or Visual Feedback Problem

  THE FOLLOWING WAS REPORTED: "IT WAS REPORTED THAT IMAGE/VIDEO IS NOT STABLE WHEN USING THE BACK VIDEO CONNECTION PORT IMAGE TURNS OFF AND BACK ON WHEN CMAC BLADE IS PLUGGED IN. ON SIDE VIDEO CONNECTION PORT IS STABLE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565656 ↗
• MalfunctionMar 4, 2026Energy Output Problem

  IT WAS REPORTED THAT "BEFORE ANESTHESIA, THE C-MAC WAS TESTED FOR USE IN INTUBATING A PATIENT. INITIALLY TESTED OK, BUT THE IMAGE FROM THE LARYNGOSCOPE HANDLE DISAPPEARS SHORTLY AFTERWARDS AND THE BATTERY INDICATOR SHOWS 0%. THE MONITOR IS LOCKED IN THE POSITION WITH AN IMAGE OF A CAMERA AND A QUESTION MARK ". PROCEDURE COMPLETED WITH DELAY LESS THAN 30 MINS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510113 ↗
• MalfunctionFeb 16, 2026No Display/Image

  IT WAS REPORTED THAT WHEN THE MONITOR IS TURNED ON, IT DOES NOT DISPLAY ANY IMAGE, IT FREEZES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24354523 ↗
• MalfunctionDec 18, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT: USER REPORTS THAT WHEN CONNECTING THE 8404AXC AND 11302BDX TO ENABLE DUAL-SCREEN MODE, THE DISPLAY BLACKS OUT AFTER SEVERAL MINUTES. WE CONNECTED 8404AXC AND 11302BDX AND CHECKED THE PHENOMENON WITH DUAL-SCREEN DISPLAY, BUT WE DID NOT OBSERVE THE BLACKOUT ISSUE WITHIN A FEW MINUTES. NO PATIENT INVOLVEMENT REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839460 ↗
• MalfunctionDec 15, 2025Device Reprocessing Problem; No Display/Image; Poor Quality Image; Device Reprocessing Problem; No Display/Image; Poor Quality Image

  IT WAS REPORTED THAT THE MONITOR FREEZES A FEW SECONDS DURING INTUBATION, AND THE FREEZE IS FOLLOWED BY A RESTART OF THE EQUIPMENT. AFTER THE RESTART THE PROCEDURE CAN CONTINUE AND BE COMPLETED. THIS ERROR HAS NOT RESULTED IN ANY ADVERSE EVENTS. ACCORDING TO THE HEALTHCARE PROVIDER THE PRODUCT WAS RETURNED TO STORZ IN AUGUST. SINCE THEN, THEY HAVE A LOAN MONITOR. THE SAME INCIDENT HAS HAPPENED WITH THE LOAN MONITOR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. PLEASE SEND A MIR FOR THE INCIDENT WITH THE LOANER EQUIPMENT WITH THE SAME ISSUE. DUE TO A REQUEST BY THE SWEDISH COMPETENT AUTHORITY, THIS CASE IS NOW DEEMED REPORTABLE FOR SWEDEN. BASED ON THE ABOVE-MENTIONED EVALUATION, THE REPORTING DECISION FOR US AND ROW IS STILL ADEQUATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804833 ↗
• MalfunctionDec 10, 2025Device Reprocessing Problem; Poor Quality Image; Optical Problem; Device Reprocessing Problem; Poor Quality Image; Optical Problem

  THE FOLLOWING WAS REPORTED: THERE IS DIFFICULTY TO VIEW THE IMAGE ON THE CMAC MONITOR. THE LIGHT INTENSITY ON THE CMAC MONITOR APPEARS TO BE VERY DIM. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23770496 ↗
• MalfunctionDec 3, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT UPON TURNING ON THE CMAC SCREEN, THE BATTERY APPEARED EMPTY AND NO IMAGE WAS DISPLAYED. AFTER RESTARTING THE DEVICE, IT FUNCTIONED NORMALLY AND THE BATTERY INDICATOR SHOWED 99%. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706713 ↗
• MalfunctionNov 25, 2025Device Reprocessing Problem; No Display/Image; Poor Quality Image; Device Reprocessing Problem; No Display/Image; Poor Quality Image

  IT WAS REPORTED THAT "NO IMAGE DURING USE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23652097 ↗
• MalfunctionNov 4, 2025Break; Optical Problem; Break; Optical Problem

  IT WAS REPORTED THAT IMAGE GETS DARK WHEN BLADE IS CONTACT WITH METAL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465912 ↗
• MalfunctionSep 11, 2025Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up

  IT WAS REPORTED THAT WHEN STARTING THE MONITOR DOESN'T GO ON. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033490 ↗
• MalfunctionAug 28, 2025Premature Discharge of Battery; Electrical /Electronic Property Problem; Premature Discharge of Battery; Electrical /Electronic Property Problem

  THE FOLLOWING WAS REPORTED: "DEVICE DOES NOT CHARGE THE BATTERY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916083 ↗
• MalfunctionJul 7, 2025Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Image Display Error/Artifact; Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Image Display Error/Artifact

  IT WAS REPORTED THAT THE CUSTOMER COMPLAINED THAT ON THE C-MAC MONITOR SOMETIMES THE IMAGE IS FROZEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414022 ↗
• MalfunctionJul 2, 2025Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  IT WAS REPORTED THAT "THE MONITOR FREEZES A FEW SECONDS DURING INTUBATION AND THE FREEZE IS FOLLOWED BY A RESTART OF THE EQUIPMENT. AFTER THE RESTART THE PROCEDURE CAN CONTINUE AND BE COMPLETED. THIS ERROR HAS NOT RESULTED IN ANY ADVERSE EVENTS." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384394 ↗
• MalfunctionJun 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE C MAC MONITOR FROZE AND RESTARTED TO THE START UP SCREEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL PROLONGATION OF LESS THAN 15 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318546 ↗
• MalfunctionJun 20, 2025Premature Discharge of Battery; Optical Problem; Premature Discharge of Battery; Optical Problem

  IT WAS REPORTED THAT THERE WAS A BAD IMAGE AND BLACKOUTS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22302005 ↗
• InjuryJun 18, 2025Output Problem; Output Problem

  DURING INTUBATION OF A CRITICAL PATIENT IN THE INTENSIVE CARE UNIT, THE USERS SWITCHED ON THE DEVICE AND CONNECTED IT TO A POWER OUTLET. AFTER THE PATIENT HAD BEEN SEDATED AND CURARISED, THE BLADE WAS INSERTED INTO THE MOUTH. AT THIS POINT, THE DEVICE'S SCREEN SWITCHED OFF AND THERE WAS NO WAY TO SWITCH IT BACK ON. ANOTHER SIMILAR DEVICE HAD TO BE USED AS AN EMERGENCY MEASURE. THE PATIENT DID NOT SUFFER ANY SERIOUS CLINICAL CONSEQUENCES AS A RESULT OF THIS ERROR.

  Patient problems: Insufficient Information

  MAUDE report 22287483 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  DURING INTUBATION OF A CRITICAL PATIENT IN THE INTENSIVE CARE UNIT, THE USERS SWITCHED ON THE DEVICE AND CONNECTED IT TO A POWER OUTLET. AFTER THE PATIENT HAD BEEN SEDATED AND CURARISED, THE BLADE WAS INSERTED INTO THE MOUTH. AT THIS POINT, THE DEVICE'S SCREEN SWITCHED OFF AND THERE WAS NO WAY TO SWITCH IT BACK ON. ANOTHER SIMILAR DEVICE HAD TO BE USED AS AN EMERGENCY MEASURE. THE PATIENT DID NOT SUFFER ANY SERIOUS CLINICAL CONSEQUENCES AS A RESULT OF THIS ERROR.

  Patient problems: Insufficient Information

  MAUDE report 22287481 ↗
• MalfunctionJun 12, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT, UNFORTUNATELY, OUR C-MAC 8403ZX HAS SUFFERED ANOTHER FAILURE. DURING GLOTTIS PASSAGE, BOTH SCREENS SUDDENLY FAILED WITHOUT ANY WARNING. INITIALLY, A DARK SCREEN APPEARED, FOLLOWED SHORTLY AFTERWARDS BY A FROZEN IMAGE AND THEN UNDEFINED IMAGE FRAGMENTS. A SECOND BRONCHOSCOPE ALSO SHOWED NOTHING. CHANGING THE AVAILABLE CONNECTIONS WAS ALSO UNSUCCESSFUL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199325 ↗
• MalfunctionMay 20, 2025Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED THAT WHEN THE FIVE S 5.3 IS CONNECTED TO THE C-MAC MONITOR, THE LIGHT DOESN'T TURN ON. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057254 ↗
• MalfunctionMay 14, 2025Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MONITOR FROZE DURING INTUBATION AND COULD NO LONGER BE OPERATED. THE DEVICE ALSO SMELLED BURNT ON RECEIPT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22020197 ↗
• MalfunctionApr 30, 2025No Display/Image; Electrical /Electronic Property Problem; No Display/Image; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT ERRORS PERSIST: MONITOR IMAGE SIMPLY FREEZES (IN THE MIDDLE OF THE EXAMINATION). MONITOR SIMPLY SWITCHES OFF IN THE MIDDLE AND THEN RESTARTS VIDEO BUTTON CAN NO LONGER BE OPERATED OR STOPPED, ETC. UNFORTUNATELY, THESE ERRORS ONLY OCCUR SPORADICALLY AND CANNOT BE REPRODUCED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935962 ↗
• MalfunctionApr 24, 2025Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED THAT THERE WAS DIM LIGHT DURING USE. ANOTHER BLADE WAS OPENED AND USED WITH SUCCESS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905787 ↗