Universal table top 116010B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046768133679), received between Nov 24, 2023 and May 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Circuit Failure; Positioning Failure; Circuit Failure; Positioning Failure

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 116010B0 - UNIVERSAL TABLE TOP, SFC, EU USED WITH 1160 OTESUS OR TABLE COLUMN AND 100925A0 UNIVERSAL CONTROL DEVICE. AS IT WAS STATED, THE OPERATING TABLE COULD ONLY BE MOVED DOWN SPORADICALLY WITH THE PATIENT LYING ON HIS STOMACH. THE HAND CONTROL AND OVERRIDE PANEL DID NOT WORK. AFTER A WHILE, THE TABLE RESPONDED AGAIN. 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 19368815 ↗
• MalfunctionMay 22, 2024Circuit Failure; Positioning Failure; Circuit Failure; Positioning Failure

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 116010B0 - UNIVERSAL TABLE TOP, SFC, EU USED WITH 1160 OTESUS OR TABLE COLUMN AND 100925A0 UNIVERSAL CONTROL DEVICE. AS IT WAS STATED, THE OPERATING TABLE COULD ONLY BE MOVED DOWN SPORADICALLY DURING A FOREARM OPERATION ON THE ANESTHETIZED PATIENT. THE HAND CONTROL AND OVERRIDE PANEL DID NOT WORK. 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 19368814 ↗
• MalfunctionNov 24, 2023Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  ON 17TH NOVEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 116010B0 - UNIVERSAL TABLE TOP, SFC, EU USED WITH 113353BC - PAIR OF LEG PLATES WITH CODE PLUG. AS IT WAS STATED, THE FOLLOWING COURSE OF EVENTS OCCURRED. ON (B)(6) 2023, THE PATIENT HAD A CESAREAN SECTION. WHEN CLOSING THE WOUND, THE PATIENT'S LEGS WERE RAISED AND FOLDED TOGETHER WHICH RESULTED IN INCREASED PRESSURE ON THE TISSUE ON THE LOWER BACK. NO FURTHER OR ADDITIONAL MEDICAL TREATMENT WAS NECESSARY IN THE CLINIC AND THE PATIENT WAS DISCHARGED AFTER A STANDARD HOSPITAL STAY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CALLED THE DELIVERY ROOM AND REPORTED THAT SHE HAD DISCOVERED A PRESSURE POINT ON HER BACK. ACCORDING TO THE CUSTOMER'S ALLEGATION, CHANGING OF THE OPERATING TABLES INCREASED THE RISK OF SKIN DAMAGE. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE PATIENT EXPERIENCING PRESSURE POINTS AFTER PROCEDURE ON THE 116010B0 - UNIVERSAL TABLE TOP, WAS TO REOCCUR.

  Patient problems: Localized Skin Lesion

  MAUDE report 18203338 ↗