OTESUS operating table system 116001D0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046768122161), received between Apr 2, 2024 and Jun 3, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Device Tipped Over

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE 116001D0 - OR TABLE COLUMN, MANOEUVRABLE. AS IT WAS STATED, WHILE USING THE DOWN FUNCTION IN THE REVERSE TRENDELENBURG POSITION, THE COLUMN ROSE SEVERAL CENTIMETERS ABOVE THE FLOOR BEFORE SUDDENLY DROPPING BACK DOWN, STRIKING THE SURGEON¿S FOOT. THE INJURY SUSTAINED REQUIRED SURGICAL INTERVENTION. NO OTHER INJURIES WERE REPORTED. WE HAVE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY SUSTAINED BY THE SURGEON.

  Patient problems: Crushing Injury

  MAUDE report 25374616 ↗
• InjuryJun 3, 2026Device Tipped Over

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE 116001D0 - OR TABLE COLUMN, MANOEUVRABLE. AS IT WAS STATED, WHILE USING THE DOWN FUNCTION IN THE REVERSE TRENDELENBURG POSITION, THE COLUMN ROSE SEVERAL CENTIMETERS ABOVE THE FLOOR BEFORE SUDDENLY DROPPING BACK DOWN, STRIKING THE SURGEON¿S FOOT. THE INJURY SUSTAINED REQUIRED SURGICAL INTERVENTION. NO OTHER INJURIES WERE REPORTED. WE HAVE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY SUSTAINED BY THE SURGEON.

  Patient problems: Crushing Injury

  MAUDE report 25372449 ↗
• MalfunctionFeb 4, 2026Positioning Failure

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE 116001D0 - OR TABLE COLUMN, MANOEUVRABLE. AS IT WAS STATED, DURING PLASTIC SURGERY BREAST OPERATION AN ATTEMPT WAS MADE TO CHANGE THE PATIENT'S SURGICAL POSITION USING THE REMOTE CONTROL, HOWEVER, THE TABLE DID NOT MOVE. THE SURGICAL POSITION COULD NOT BE CHANGED TO AN OPTIMAL ONE. DUE TO THE SURGEONS POOR WORKING POSITION, THE SUTURE AND ISCHEMIA TIME WAS PROLONGED. 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, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255478 ↗
• MalfunctionSep 6, 2024Circuit Failure; Positioning Failure; Circuit Failure; Positioning Failure

  ON 23RD AUGUST 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001D0 - OR TABLE COLUMN, MANOEUVRABLE. AS IT WAS STATED, THE TABLE STOPPED IN THE MIDDLE OF THE OPERATION. THE TABLE COULD NOT BE OPERATED VIA THE REMOTE CONTROL OR OVERRIDE PANEL. ALL BUTTON LIGHTS WERE FLASHING IN THE COLUMN AND THE TABLE DID NOT GO TO SLEEP MODE. NO ERROR CODES WERE DISPLAYED ON THE REMOTE CONTROL. 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 TABLE DURING PROCEDURE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155881 ↗
• MalfunctionApr 2, 2024Failure to Charge; Positioning Failure; Failure to Run on Battery; Failure to Charge; Positioning Failure; Failure to Run on Battery

  ON 18TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 116001D0 - OR TABLE COLUMN, MANOEUVRABLE. AS IT WAS STATED, THE TABLE COULD NOT BE OPERATED VIA THE IR REMOTE NOR THE EMERGENCY REMOTE AT THE END OF CRITICAL NEUROLOGICAL SURGERY ON THE ANESTHETIZED PATIENT. THERE WAS NO DELAY AS THE FAILURE OCCURRED JUST WHEN THE SURGERY WAS FINISHED. THE TABLE WAS REPLACED AND THE HOSPITAL PROGRAM CONTINUED. ACCORDING TO INFORMATION PROVIDED BY GETINGE SERVICE TECHNICIAN, THE BATTERIES WERE DISCHARGED AND THE TABLE WORKED PROPERLY AFTER CONNECTING TO THE POWER SUPPLY. IN ADDITION, THE TABLE SUFFERED AN IMPACT TO THE FAIRINGS AND THE FRAME SUPPORTING THEM WAS BROKEN. AS THE RESULT, THE CONNECTION CABLE OF ONE OF THE I/O CARDS WAS DAMAGED AND BLOCKED THE TABLE. 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 TABLE, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017896 ↗