Universal table top 116010D0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046768133709), received between Mar 6, 2023 and Oct 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Interrogate” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2023Positioning Failure; Failure to Interrogate; Positioning Failure; Failure to Interrogate

  ON 25TH SEPTEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 116010D0 - UNIVERSAL TABLE TOP, IPC, EU, WASHABLE USED WITH 116001A0 - OTESUS OR TABLE COLUMN, STATIONARY. AS IT WAS STATED, THE HEIGHT OF THE COLUMN COULD NOT BE LOWERED AND THE STAFF HAD TO OPERATE ON THE ELEVATED OPERATING TABLE TOP. THE ISSUE LED TO A SHORT DELAY OF UNDER TWO MINUTES IN THE OPERATION ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902621 ↗
• MalfunctionMar 6, 2023Positioning Problem; Positioning Problem

  ON 16TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS ¿ 116010D0 - UNIVERSAL TABLE TOP, IPC, EU, WASHABLE. AS IT WAS STATED, THE PATIENT SLIPPED ON THE TABLE TOP AFTER BEING POSITIONED INTO 20 DEGREE TRENDELENBURG. THE STAFF WAS ABLE TO PREVENT THE PATIENT FROM FALLING. THE SURGERY WAS INTERRUPTED AS THE PATIENT REQUIRED REPOSITIONING WHICH RESULTED IN A DELAY OF APPROXIMATELY 1 HOUR. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY PATIENT SLIPPING ON THE TABLE TOP WHICH COULD LEAD TO PATIENT'S FALL OR DELAY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491976 ↗