MAGNUS operating table system 118001B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046768031531), received between Nov 16, 2023 and Nov 16, 2023 — classified as 1 malfunction.

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

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Positioning Failure; Positioning Failure

  ON 7TH NOVEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B0 - MAGNUS OP TABLE COLUMN - SURFACE MOUNTED. AS IT WAS STATED, THE TABLE COULD NO LONGER MAKE CERTAIN MOVEMENTS DURING THE PROCEDURE DUE TO MALFUNCTION OF HYDRAULIC PUMP LEADING TO TERMINATION OF THE CURRENT OPERATION AND CANCELLATION OF THE REST OF THE SURGICAL PROGRAM. THE TABLE WAS MALFUNCTIONING DURING "UP" MOVEMENT AND IN THE TRANSLATION POSITION ON THE LEG SIDE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY INABILITY TO POSITION PATIENT AS REQUIRED DUE TO MALFUNCTION OF HYDRAULIC PUMP LEADING TO TERMINATION OF THE SURGERY, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148987 ↗