OTESUS operating table system 116001A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04046768100657), received between Oct 17, 2023 and Apr 16, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (12 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Electrical /Electronic Property Problem

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE 116001A0: OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED DURING A ROBOTIC PROCEDURE, THE OPERATING TABLE UNEXPECTEDLY MOVED FROM A HEAD-DOWN POSITION TO A HORIZONTAL POSITION, AND THE LEGS RETURNED TO THEIR NEUTRAL ORIENTATION, WHILE THE DA VINCI SYSTEM REMAINED DOCKED WITH INSTRUMENTS INSERTED. THE SURGERY WAS COMPLETED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY UNINTENDED MOVEMENT RESULTING IN CHANGE OF THE POSITION OF THE PATIENT, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895608 ↗
• MalfunctionMay 7, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE COLUMN WAS NO LONGER RESPONDING AND COULD NOT BE OPERATED WITH THE WIRED REMOTE CONTROL OR THE OVERRIDE PANEL DURING PELVISCOPY. THE ISSUE RESULTED IN A DELAY AND PROLONGED ANESTHESIA TIME FOR THE PATIENT. DURING A SERVICE VISIT ON SITE, A HINGED COVER WAS FOUND TO BE MISSING, WHICH COULD ALLOW FLUID TO PENETRATE AND CAUSE PROBLEMS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO THE REMOTE CONTROL OR OVERRIDE PANEL, LEADING TO INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974071 ↗
• MalfunctionMay 7, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE COLUMN WAS NO LONGER RESPONDING AND COULD NOT BE OPERATED WITH THE WIRED REMOTE CONTROL OR THE OVERRIDE PANEL DURING PELVISCOPY. THE ISSUE RESULTED IN A DELAY AND PROLONGED ANESTHESIA TIME FOR THE PATIENT. DURING A SERVICE VISIT ON SITE, A HINGED COVER WAS FOUND TO BE MISSING, WHICH COULD ALLOW FLUID TO PENETRATE AND CAUSE PROBLEMS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO THE REMOTE CONTROL OR OVERRIDE PANEL, LEADING TO INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974070 ↗
• MalfunctionMay 7, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE COLUMN WAS NO LONGER RESPONDING AND COULD NOT BE OPERATED WITH THE WIRED REMOTE CONTROL OR THE OVERRIDE PANEL DURING PELVISCOPY. THE ISSUE RESULTED IN A DELAY AND PROLONGED ANESTHESIA TIME FOR THE PATIENT. DURING A SERVICE VISIT ON SITE, A HINGED COVER WAS FOUND TO BE MISSING, WHICH COULD ALLOW FLUID TO PENETRATE AND CAUSE PROBLEMS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO THE REMOTE CONTROL OR OVERRIDE PANEL, LEADING TO INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974067 ↗
• MalfunctionMay 7, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE COLUMN WAS NO LONGER RESPONDING AND COULD NOT BE OPERATED WITH THE WIRED REMOTE CONTROL OR THE OVERRIDE PANEL DURING PELVISCOPY. THE ISSUE RESULTED IN A DELAY AND PROLONGED ANESTHESIA TIME FOR THE PATIENT. DURING A SERVICE VISIT ON SITE, A HINGED COVER WAS FOUND TO BE MISSING, WHICH COULD ALLOW FLUID TO PENETRATE AND CAUSE PROBLEMS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO THE REMOTE CONTROL OR OVERRIDE PANEL, LEADING TO INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974064 ↗
• MalfunctionMay 7, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE COLUMN WAS NO LONGER RESPONDING AND COULD NOT BE OPERATED WITH THE WIRED REMOTE CONTROL OR THE OVERRIDE PANEL DURING PELVISCOPY. THE ISSUE RESULTED IN A DELAY AND PROLONGED ANESTHESIA TIME FOR THE PATIENT. DURING A SERVICE VISIT ON SITE, A HINGED COVER WAS FOUND TO BE MISSING, WHICH COULD ALLOW FLUID TO PENETRATE AND CAUSE PROBLEMS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO THE REMOTE CONTROL OR OVERRIDE PANEL, LEADING TO INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974063 ↗
• MalfunctionMay 7, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE COLUMN WAS NO LONGER RESPONDING AND COULD NOT BE OPERATED WITH THE WIRED REMOTE CONTROL OR THE OVERRIDE PANEL DURING PELVISCOPY. THE ISSUE RESULTED IN A DELAY AND PROLONGED ANESTHESIA TIME FOR THE PATIENT. DURING A SERVICE VISIT ON SITE, A HINGED COVER WAS FOUND TO BE MISSING, WHICH COULD ALLOW FLUID TO PENETRATE AND CAUSE PROBLEMS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO THE REMOTE CONTROL OR OVERRIDE PANEL, LEADING TO INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974062 ↗
• MalfunctionMay 6, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE COLUMN WAS NO LONGER RESPONDING AND COULD NOT BE OPERATED WITH THE WIRED REMOTE CONTROL OR THE OVERRIDE PANEL DURING PELVISCOPY. THE ISSUE RESULTED IN A DELAY AND PROLONGED ANESTHESIA TIME FOR THE PATIENT. DURING A SERVICE VISIT ON SITE, A HINGED COVER WAS FOUND TO BE MISSING, WHICH COULD ALLOW FLUID TO PENETRATE AND CAUSE PROBLEMS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO THE REMOTE CONTROL OR OVERRIDE PANEL, LEADING TO INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965975 ↗
• MalfunctionJun 20, 2024Positioning Failure; Failure to Interrogate; Positioning Failure; Failure to Interrogate

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001A0 - OTESUS, OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE COLUMN SUDDENLY STOPPED RESPONDING TO INPUT VIA THE REMOTE CONTROL (WIRED OR WIRELESS), AS WELL AS DIRECTLY VIA THE CONTROL PANEL. THE PROBLEM OCCURRED DURING SURGERY. THE ANESTHETIZED PATIENT WAS ON THE TABLE AND THE COLUMN WAS MOVED ALL THE WAY UP. DURING INPUT ATTEMPTS, A RELAY CLICKING COULD SOMETIMES BE HEARD, BUT THE COLUMN DID NOT MOVE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO MOVE TO DIFFERENT POSITIONS USING THE CONTROL PANEL AND WIRED, REMOTE CONTROL, THE COLUMN SUDDENLY WORKED NORMALLY AGAIN EVEN WITH WIRELESS REMOTE CONTROL (FIRST, POSITION MOVED TO: LATERAL TILT). THE ISSUE RESULTED IN A FEW MINUTES OF DELAY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY OPERATING TABLE NOT RESPONDING TO REMOTE CONTROL NOR OVERRIDE PANEL LEADING TO INABILITY TO POSITION THE PATIENT AS REQUIRED, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19572877 ↗
• MalfunctionApr 5, 2024Circuit Failure; Positioning Failure; Moisture Damage; Circuit Failure; Positioning Failure; Moisture Damage

  MANUFACTURER'S REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048528 ↗
• MalfunctionFeb 23, 2024Positioning Failure; Failure to Read Input Signal; Positioning Failure; Failure to Read Input Signal

  ON 25TH JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES 100925A0 UNIVERSAL REMOTE CONTROL USED WITH 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THERE WAS NO FUNCTION WHEN RAISING THE OPERATING COLUMN WITH THE PATIENT ON THE TABLE TOP. IT WAS NOT POSSIBLE TO CONTROL THE TABLE VIA REMOTE CONTROL, CONNECTED HAND CONTROL NOR OVERRIDE PANEL. ACCORDING TO PROVIDED INFORMATION, THE COLUMN STOPPED REPEATEDLY OR REMOTE CONTROL COMMANDS WERE EXECUTED HALTINGLY. AFTER ABOUT 5 MINUTES, THE SURGICAL COLUMN WAS FULLY FUNCTIONAL AGAIN. THE SERVICE TECHNICIAN INDICATED THAT THE INCIDENT WAS CAUSED BY THE IR REMOTE CONTROL MALFUNCTION. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO REMOTE CONTROL NOR OVERRIDE PANEL LEADING TO INABILITY TO POSITION THE TABLE DURING PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766244 ↗
• MalfunctionFeb 14, 2024Positioning Failure; Failure to Read Input Signal; Positioning Failure; Failure to Read Input Signal

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100925A0 - UNIVERSAL REMOTE CONTROL USED WITH 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE TABLE COULD NO LONGER BE USED NEITHER WITH THE REMOTE CONTROL (INCLUDING CABLE CONNECTED CONTROL) NOR WITH OVERRIDE PANEL ON THE COLUMN. THE PATIENT WAS ALREADY ANESTHETIZED AND ON THE OPERATING TABLE WHEN THE ISSUE OCCURRED. THE ENTIRE SURGICAL EQUIPMENT (MIC AORTIC VALVE 3D) HAD TO BE BROUGHT TO ANOTHER OPERATING ROOM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER THE TRANSFER. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE OPERATING TABLE NOT RESPONDING TO REMOTE CONTROL OR OVERRIDE PANEL LEADING TO INABILITY TO POSITION THE PATIENT AND PROCEDURAL DELAY RELATED TO TRANSFER OF THE PATIENT TO ANOTHER OPERATING ROOM DURING PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18700956 ↗
• MalfunctionNov 24, 2023Computer Software Problem; Wireless Communication Problem; Intermittent Communication Failure; Computer Software Problem; Wireless Communication Problem; Intermittent Communication Failure

  MANUFACTURER'S REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204562 ↗
• MalfunctionOct 17, 2023Circuit Failure; Positioning Failure; Failure to Interrogate; Circuit Failure; Positioning Failure; Failure to Interrogate

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS ¿ 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE TABLE COULD NOT BE POSITIONED AS REQUIRED FOR THE EXTUBATION OF THE PATIENT. THE OPERATING TABLE TOP SHOULD BE PLACED IN THE UPPER BODY ELEVATION, HOWEVER, IT REMAINED TILTED IN THE LEFT LATERAL POSITION. THE PATIENT HAD TO BE EXTUBATED IN THIS POSITION AND TRANSFERRED TO BED AS QUICKLY AS POSSIBLE. ACCORDING TO THE PROVIDED INFORMATION, DURING SUBSEQUENT ATTEMPTS TO LEVEL THE TABLE, THE TABLE ONLY TILTED TO THE LEFT USING A WIDE VARIETY OF KEYS AND DAMAGED THE COLUMN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY INABILITY TO POSITION PATIENT AS REQUIRED, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17952807 ↗