Life Scope G9 CU-192RRecalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 04931921112168), received between Oct 21, 2016 and Sep 9, 2026 — classified as 3 deaths, 3 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Output Problem” (59 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• DeathSep 9, 2026Device Alarm System; Protective Measures Problem

  The Biomedical Engineer (BME) reported that the patient was subsequently transferred to this G9 monitor (SN: (b)(6), where the patient later passed away. They were requesting the logs to be reviewed of all involved devices prior to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700263 ↗
• MalfunctionAug 14, 2026Device-Device Incompatibility; Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50245673 ↗
• MalfunctionAug 7, 2026Tactile Prompts/Feedback; No Tactile Prompts/Feedback

  The customer reported that the Touchscreen on the G9 Monitor was not responding to touch inputs. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181733 ↗
• MalfunctionJul 22, 2026Display or Visual Feedback Problem; Output Problem; Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25905512 ↗
• DeathJun 26, 2026Display Difficult to Read; Output Problem

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT ON (B)(6) 2026 AT APPROXIMATELY 7:30AM THE G9 MONITOR DISPLAYED A "HOST MONITOR SOFTWARE TOO OLD" ERROR MESSAGE. HE STATED THAT DUE TO THE ERROR MESSAGE, THE VITALS WERE NOT DISPLAYED ON THE G9 MONITOR AND THE PATIENT EXPIRED. THE VITALS APPEARED ON THE BSM-1700, BUT WHEN IT WAS DOCKED TO THE G9, THEY DID NOT DISPLAY.

  Patient problems: Insufficient Information

  MAUDE report 25638186 ↗
• MalfunctionJun 25, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE DISPLAY SCREEN ON THE G9 MONITOR WAS FLASHING AND BLACKING OUT AND THE TOUCHSCREEN WAS UNRESPONSIVE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627976 ↗
• MalfunctionMay 12, 2026Application Program Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 BEDSIDE MONITOR DISCHARGED A PATIENT ON ITS OWN WHILE MONITORING A PATIENT. CLINICAL STAFF WAS ABLE TO READMIT THE PATIENT AND RETRIEVE THE DATA. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155709 ↗
• MalfunctionMay 4, 2026Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 BEDSIDE MONITOR BEGAN SPONTANEOUSLY REBOOTING OVER THE WEEKEND. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074814 ↗
• MalfunctionApr 20, 2026No Display/Image; Display or Visual Feedback Problem; Output Problem

  The Biomedical Engineer (BME) reported that the main display is blacked out but it will respond to touch on the G9 Bedside Monitor During the boot-up, they can see the values, but once it fully boots up, the display goes black. They rebooted 3 times, and the issue repeats. They swapped the cables and the issue repeats. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933340 ↗
• MalfunctionApr 1, 2026No Display/Image; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE LCD ON THIS DISPLAY IS NO LONGER WORKING. ACCORDING TO THE CUSTOMER, THE DISPLAY ON THIS G9 UNIT STAYS BLACK. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754149 ↗
• MalfunctionMar 11, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT APPROXIMATELY ONCE OR TWICE A MONTH, THEIR G9 UNITS IN THE ICU DEPARTMENT DISPLAY A "SYSTEM FAILURE SETTINGS" ERROR MESSAGE. THE BME STATED THAT NK TECH SUPPORT PREVIOUSLY ADVISED HER TO COLLECT THE LOG FILES FROM THE G9 SO AN IRC CAN BE INITIATED TO DETERMINE WHAT IS CAUSING THE "SYSTEM FAILURE SETTINGS" ERROR. SHE WAS ABLE TO CLEAR THE ERROR MESSAGE BY REINITIALIZING THE G9. TECH SUPPORT (TS) INFORMED HER THAT THE G9 MUST BE RUNNING SOFTWARE VERSION 01-48 OR HIGHER TO CAPTURE THE SPECIFIC ERROR LOGS NEEDED FOR REVIEW. SHE STATED THE DEVICE IN QUESTION IS CURRENTLY RUNNING VERSION 01-45, SO WE WOULD NOT BE ABLE TO DETERMINE WHAT TRIGGERED THE ERROR FROM THOSE LOGS. TS ADVISED HER THAT THE G9 UNITS NEED TO BE UPGRADED. SHE STATED SHE RECEIVED THE 01-48 SOFTWARE MEDIA TODAY. I ADVISED HER TO PROCEED WITH UPGRADING THE G9 UNITS TO VERSION 01-48 AND, IF THE ISSUE OCCURS AGAIN NOW THAT THE SOFTWARE WAS UPGRADED TO 01-48, TO PULL THE LOGS SO WE CAN SUBMIT THEM TO NKC FOR AN IRC REVIEW. SHE UNDERSTOOD. CUSTOMER PLANS TO UPGRADE G9 UNITS TO SOFTWARE VERSION 01-48. IF THE ERROR RECURS, LOGS WILL BE COLLECTED AND SUBMITTED TO NKC TO INITIATE AN IR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573562 ↗
• MalfunctionFeb 20, 2026Communication or Transmission Problem; Output Problem; Wireless Communication Problem; No Tactile Prompts/Feedback

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TOUCHSCREEN AND MOUSE ON THE G9 MONITOR WERE NOT WORKING. THEY ALSO REPORTED THAT THE DEVICE GAVE A "COMM LOSS" ERROR MESSAGE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402313 ↗
• MalfunctionFeb 12, 2026No Display/Image; Display or Visual Feedback Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE SECONDARY DISPLAY FOR THIS DUAL SCREEN G9 MONITOR WAS ONLY DISPLAYING THE NK SPLASH SCREEN WHILE IN USE IN THE OR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326545 ↗
• MalfunctionFeb 5, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THIS UNIT GOT STUCK IN A BOOT LOOP. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268727 ↗
• MalfunctionJan 27, 2026Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR WOULD DISPLAY THE NK LOGO FOR A MOMENT, THEN GO INTO A BOOT-LOOP CYCLE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192342 ↗
• MalfunctionJan 26, 2026Tactile Prompts/Feedback; No Tactile Prompts/Feedback

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TOUCHSCREEN ON THE G9 MONITOR WAS NOT WORKING. TECHNICAL SUPPORT (TS) HAD THE BME RUN THE DRIVER SETUP AND TOUCHSCREEN CALIBRATION PER THE SERVICE MANUAL, BUT WHEN ATTEMPTING TO CALIBRATE, IT COULD NOT FIND THE TOUCHSCREEN CONTROLLER. WHEN THEY WENT INTO THE GALAX TOOL TO TRY TO MANUALLY CONFIGURE THE TOUCHSCREEN, IT WOULD NOT RECOGNIZE THE CONTROLLER AT COM3. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180139 ↗
• MalfunctionJan 20, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THIS UNIT BOOT LOOP SPONTANEOUSLY. THE ISSUE WAS DISCOVERED DURING SETUP. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116429 ↗
• MalfunctionJan 20, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THIS G9 UNIT IS CONSTANTLY BOOT LOOPING. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115924 ↗
• MalfunctionJan 7, 2026Activation Problem; Key or Button Unresponsive/not Working

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR HAD A BAD CONTROLLER, AND THE TOUCHSCREEN WAS NOT RESPONDING TO TOUCH INPUTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996733 ↗
• MalfunctionDec 3, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE DISPLAY ON THE G9 MONITOR WAS INTERMITTENTLY FLASHING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706274 ↗
• MalfunctionNov 18, 2025Device Alarm System; No Audible Alarm; Alarm Not Visible; Protective Measures Problem; Device Alarm System; No Audible Alarm; Alarm Not Visible; Protective Measures Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR MISSED A VTACH ALARM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586014 ↗
• MalfunctionNov 6, 2025Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE GRAPH ON THE LEFT SIDE OF THE MONITOR DISPLAYING THE NUMERICAL VALUES OF THE ECG, HEART RATE AND SPO2 INTERMITTENTLY GO OUT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487633 ↗
• MalfunctionOct 23, 2025Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR SHUT DOWN DURING A CASE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373246 ↗
• MalfunctionSep 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CHARGE NURSE REPORTED THAT THE G9 MONITOR DID NOT ALARM FOR SPO2. THE SPO2 DROPPED TO 44 WHEN THE ALARM LIMIT WAS SET AT 89, WHICH SHOULD HAVE TRIGGERED AN ALARM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028414 ↗
• MalfunctionAug 4, 2025Power Problem; Complete Loss of Power; Power Problem; Complete Loss of Power

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE G9 MONITOR POWERED OFF AT THE END OF AN ANESTHESIA CASE IN OR1 ON (B)(6) 2025 AT 1630 HOURS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701659 ↗