MAGNUS operating table system 118001D0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046768031579), received between Aug 31, 2023 and Mar 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 11, 2021Open, Classified

   There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.

   Z-1296-2021 · Root cause: Device Design · FDA record ↗

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.

• MalfunctionMar 20, 2024Positioning Failure; Positioning Failure

  ON 13TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001D0 - MAGNUS OR-TABLE COLUMN, INDEPEN. AS IT WAS STATED, THE OPERATING TABLE COULD NO LONGER BE MOVED TO 0 POSITION FROM THE LATERAL TILTING OF THE TABLE DURING A SURGERY ON AN ANESTHETIZED PATIENT. THE MOTORS COULD BE HEARD VERY QUIETLY, HOWEVER, THERE WAS NO MOVEMENT IN THE MODULES. IF THE MODULES WERE CONTROLLED SEPARATELY, THEY WORKED WITH A DELAY. NO ERROR MESSAGE WAS DISPLAYED ON THE REMOTE CONTROL. THE EMERGENCY PANEL DID NOT WORK AS WELL. AFTER APPROXIMATELY 10 MINUTES FROM THE LAST MANEUVER, THE TILTING COULD BE CANCELLED BY REMOTE CONTROL, HOWEVER, IT WAS STILL IMPOSSIBLE TO MOVE THE TABLE INTO 0 POSITION. AT THE TIME OF INCIDENT, THE TABLE BASE WAS CONNECTED TO THE POWER SUPPLY. THE ISSUE RESULTED IN A DELAY AS THE PATIENT COULD NOT BE POSITIONED PROPERLY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF SITUATIONS, NAMELY OPERATING TABLE NOT RESPONDING TO REMOTE CONTROL NOR OVERRIDE PANEL LEADING TO INABILITY TO POSITION THE PATIENT AS REQUIRED AND THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WERE TO REOCCU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941432 ↗
• MalfunctionAug 31, 2023Positioning Failure; Battery Problem; Positioning Failure; Battery Problem

  ON 18TH AUGUST 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS ¿ 118001D0 MAGNUS OR-TABLE COLUMN, INDEPENDENTLY MANOEUVRABLE. AS IT WAS STATED, AT THE BEGINNING OF BILLARY SURGERY AFTER GAS FILLING HAD BEEN DONE, THE TABLE DID NOT MOVE INTO THE INDICATED POSITION. THE ERROR 159/7 (GENERAL ERROR COLUMN) WAS DISPLAYED ON THE REMOTE CONTROL. BASED ON THE PROVIDED INFORMATION, THE BATTERY WAS DEPLETED DESPITE THE FACT THAT THE POWER CORD OF THE TABLE WAS CONNECTED. ACCORDING TO THE CUSTOMER ALLEGATION, THERE WERE NO ACOUSTIC SIGNALS INDICATING THE BATTERY CHARGE IS RUNNING OUT. THE PROCEDURE WAS COMPLETED ON THE AFFECTED TABLE. THE PATIENT WAS NOT ENDANGERED, HOWEVER, THE ISSUE MADE THE OPERATION CONSIDERABLY MORE DIFFICULT LEADING TO A DELAY IN A SURGERY ON THE ANESTHETIZED PATIENT. WE DECIDED TO REPORT THE ISSUE AS A DELAY OF SURGERY, RESULTING IN PROLONGED ANESTHESIA TIME, COULD LEAD TO SERIOUS INJURY IN CASE OF EVENT RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661929 ↗