MAGNUS operating table system 118001B1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046768040700), received between Sep 12, 2023 and Jun 5, 2024 — classified as 4 malfunctions.

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

• MalfunctionJun 5, 2024Computer Software Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Computer Software Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  ON 22ND MAY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS 9118001B1 HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, THERE WAS AN INTERNAL COMMUNICATION ISSUE WITH THE TABLE CONTROLS - NOT ACKNOWLEDGING BREAK SYSTEM AND NOT RECOGNIZING THE TABLE. THE USE OF THE TABLE WAS LIMITED WHAT LED TO AN 1 HOUR DELAY IN CRITICAL HEART SURGERY ON THE ANESTHETIZED PATIENT. EVENTUALLY, THE SURGERY HAD TO BE RESCHEDULED. THE CUSTOMER TESTED THE GENERATORS AND CONCLUDED THAT SEVERAL PIECES OF EQUIPMENT HAD TROUBLE AFTERWARDS. THE TABLE REQUIRED A HARD RESET INVOLVING REMOVING TABLE POWER AND RESTARTING IT. FOLLOWING SERVICE VISIT ON SITE IT WAS CONFIRMED THAT THE PROBLEM WAS FIXED WITH THE HARD RESET. 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 OR POSTPONEMENT OF CRITICAL SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465422 ↗
• MalfunctionMar 28, 2024Failure to Sense; Communication or Transmission Problem; Air/Gas in Device; Failure to Sense; Communication or Transmission Problem; Air/Gas in Device

  ON 25TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B1 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, THE CONNECTION WITH THE ANGIOGRAPHY DEVICE (PHILIPS AZURION 7 M20) WAS INTERRUPTED DURING SURGERY. THE PATIENT WAS ALREADY UNDER ANESTHESIA. DUE TO THE ISSUE, THE INCISION HAD TO BE CLOSED, THE SURGERY WAS INTERRUPTED AND RESCHEDULED TO THREE DAYS LATER. THE TECHNICIAN INDICATED THAT THE AIR WAS MIXED IN THE VERTICAL TILT CYLINDER CAUSING THE SENSOR VALUES TO BECOME UNSTABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE RESCHEDULING OF THE SURGERY ON THE ALREADY ANESTHETIZED PATIENT, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990020 ↗
• MalfunctionNov 24, 2023Positioning Failure; Positioning Failure

  ON 11TH NOVEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS - 118001B1 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, DURING URGENT EVAR ON A SYMPTOMATIC ABDOMINAL AORTIC ANEURYSM WITH IMPENDING RUPTURE, THE DEVICE MALFUNCTIONED EARLY IN THE PROCEDURE AND BECAME IMMOVABLE. THE STAFF TRIED TO USE THE HAND CONTROL BUTTONS COMBINATION TO RESET COMMUNICATION BETWEEN THE COLUMN AND PHILIPS AZURION ANGIOGRAPHY SYSTEM WITHOUT SUCCESS. ACCORDING TO THE PROVIDED INFORMATION, THERE WAS NO RESPONSE FROM THE COLUMN EVEN WHEN THE OVERRIDE PANEL WAS USED, AND THE STAFF WAS FORCED TO PERFORM A TOTAL RESET BY REMOVING THE FUSE IN THE POWER SUPPLY OF THE DEVICE IN THE TECHNICAL ROOM. FORTUNATELY, THE C-ARM WAS WORKING, AND THE SURGEON MANAGED TO COMPLETE THE PROCEDURE WITHOUT MOVEMENT OF THE TABLE. THE ISSUE LED TO A DELAY IN AN EMERGENCY SURGERY 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 INABILITY TO MOVE THE DEVICE EVEN WITH THE USE OF THE OVERRIDE PANEL, DELAY IN TREATMENT IN EMERGENCY SURGERY, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18203459 ↗
• MalfunctionSep 12, 2023Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  ON 4TH SEPTEMBER 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR COLUMNS ¿ 118001B1 HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AS IT WAS STATED, THE CONNECTION BETWEEN 118001B1 HYBRID OR TABLE COLUMN, SURFACE-MOUNTED AND PHILIPS C-ARM WAS CUT OFF DURING THE SURGERY (TAVI) ON THE ANESTHETIZED PATIENT. THE SURGERY WAS DELAYED BY 30 MINUTES. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO A DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME. ACCORDING TO THE SUBJECT MATTER EXPERT'S ASSESSMENT OF THE ERROR LOGS, THE INCIDENT IS TRACED TO THE KNOWN ISSUE WITH THE PHILIPS SYSTEM RELATED TO THE VIOLATION OR THE MISUSE OF THE INTERFACE SPECIFICATION BY THE INTERFACE PARTNER. AS THE CAUSE OF THE MALFUNCTION WAS TRACED TO DEVICE MANUFACTURED BY PHILIPS, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17727041 ↗