Modular universal table top 115030B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046768003347), received between Mar 7, 2024 and Dec 6, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864954 ↗
• MalfunctionNov 18, 2024Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 115030B0 - MODULAR UNIVERSAL TABLE TOP. AS IT WAS STATED, THE UPPER BACK PART OF THE OPERATING BOARD RELEASED UPON LOADING WITH AN ANESTHETIZED PATIENT WITH A HIGHER WEIGHT RESULTING IN CHANGE IN THE PATIENT'S POSITION DURING UNSPECIFIED LEG/KNEE SURGERY. THE STAFF WAS ABLE TO CAPTURE AND STABILIZE THE LOOSE BACK PART WITH THE PATIENT. THE INCIDENT RESULTED IN A NON-SIGNIFICANT DELAY. ACCORDING TO PROVIDED INFORMATION, AT THE TIME OF INCIDENT, THE PATIENT WAS SECURED WITH BELTS. 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 OF THE TABLE DURING SURGERY CREATING A RISK OF NERVE OVERSTRETCHING, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704044 ↗
• MalfunctionApr 30, 2024Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

  ON 16TH APRIL 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 115030B0 - MODULAR UNIVERSAL TABLE TOP. AS IT WAS STATED, A HEAD REST LOWERED DURING A SURGERY. IT WAS CONFIRMED THAT THE MOVEMENT WAS FAST AND AN ANESTHETIZED PATIENT WAS ON THE TABLE WHEN THE ISSUE OCCURRED. ACCORDING TO THE PROVIDED INFORMATION, THE HEAD RESTRAINT LATCHES DID NOT LOCK AND GAVE IN EASILY. FOLLOWING SERVICE VISIT ON SITE, IT WAS CONFIRMED THAT THERE WAS AN ISSUE AT THE TABLE TOP. THE MOTORS WERE MISALIGNED AND THE HEAD REST FIXING SYSTEM WAS WORN. 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 OF THE TABLE CREATING A RISK OF NERVE OVERSTRETCHING, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211346 ↗
• MalfunctionMar 7, 2024Failure to Conduct; Positioning Failure; Failure to Conduct; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855305 ↗