Universal remote device 100925A0Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046768134294), received between Mar 28, 2023 and Oct 3, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Unexpected Shutdown; Unexpected Shutdown

  ON 23RD SEPTEMBER 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100925A0 - UNIVERSAL REMOTE CONTROL. AS IT WAS STATED, THE REMOTE CONTROL SWITCHED OFF WHILE POSITIONING THE PATIENT ON THE OR-TABLE FOR AN URGENT C-SECTION OPERATION. WHEN THE ISSUE OCCURRED, THE CUSTOMER PRESSED THE ¿ON¿ BUTTON FOR APPROXIMATELY 30 SECONDS BEFORE THE DISPLAY TURNED ON. THE USERS DID NOT USE THE OVERRIDE PANEL, HOWEVER, THEY WERE ABLE GET THE REMOTE CONTROL ON AND CONTINUE THE OPERATION. THE ISSUE RESULTED IN A DELAY OF 2 TO 5 MINUTES. 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 EMERGENCY SURGERY, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357664 ↗
• MalfunctionDec 15, 2023Wireless Communication Problem; Wireless Communication Problem

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100925A0 - UNIVERSAL REMOTE CONTROL. ACCORDING TO THE CUSTOMER ALLEGATION, THE IR-CODE OF REMOTE CONTROL CHANGED ITSELF DURING THE OPERATION AND THE CONTROL COULD NOT BE USED. THE MALFUNCTION RESULTED IN APPROXIMATELY 30-MINUTE DELAY IN PROCEDURE UNTIL A REPLACEMENT REMOTE CONTROL WAS BROUGHT. IN THE MEANTIME, THE TABLE WAS OPERATED WITH THE OVERRIDE PANEL. THE SURGERY WAS COMPLETED AS PLANNED. THE PATIENT WAS UNDER ANESTHESIA AND ON A HEART-LUNG MACHINE WHEN THE ISSUE OCCURRED. 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 18334064 ↗
• MalfunctionOct 12, 2023Communication or Transmission Problem; Positioning Problem; Unexpected Shutdown; Communication or Transmission Problem; Positioning Problem; Unexpected Shutdown

  ON 2ND OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100925A0 UNIVERSAL REMOTE CONTROL. AS IT WAS STATED, THE IR CODE ON THE UNIVERSAL REMOTE CONTROL WAS CHANGED DURING A KNEE PROSTESIS OPERATION ON THE ANESTHETIZED PATIENT. ACCORDING TO THE CUSTOMER'S ALLEGATION, THE COLUMN COULD NO LONGER BE CONTROLLED DUE TO THE ISSUE AND THE TABLETOP COULD NOT BE ADJUSTED. THE ISSUE LED TO A DELAY OF APPROXIMATELY 3 MINUTES AS THE STAFF TRIED TO ORGANIZE A REPLACEMENT REMOTE CONTROL. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE DUE TO A DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED AS ACCORDING TO THE MEDICAL EXPERT'S ASSESSMENT, THE PROCEDURAL DELAY DID NOT HAVE ANY MAJOR CLINICAL RELEVANCE IN THIS SITUATION. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919485 ↗
• MalfunctionJun 26, 2023Unexpected Shutdown; Unexpected Shutdown

  ON 12TH JUNE 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100925A0 - UNIVERSAL REMOTE CONTROL USED WITH 116001B0 OTESUS OR TABLE COLUMN, STATIONARY. ACCORDING TO THE INITIALLY PROVIDED INFORMATION, A TOUCHSCREEN OF THE REMOTE CONTROL WENT INTO DEEPSLEEP MODE. ON 21ST JUNE 2023, ADDITIONAL DETAILS WERE RECEIVED. IT HAS BEEN CLARIFIED THAT THE INCIDENT OCCURRED DURING SURGERY. THE STAFF WAS TRYING TO FIGURE OUT WHAT WAS WRONG WITH THE HANDCONTROL AND WAS ABLE TO SOLVE THE PROBLEM WITH ON/OFF BUTTON. THE ISSUE RESULTED IN APPROXIMATELY 5 MINUTES DELAY IN A SURGERY ON THE ANESTHETIZED PATIENT. THERE WAS NO INJURY OF THE PATIENT REPORTED, HOWEVER, 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 17198978 ↗
• MalfunctionApr 5, 2023Unexpected Shutdown; Unexpected Shutdown

  ON 30TH MARCH 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100925A0 - UNIVERSAL REMOTE CONTROL USED WITH 116010A0 UNIVERSAL TABLE TOP, IPC, EU. DURING THE GYNECOLOGICAL PROCEDURE, WHILE THE STAFF TRIED TO LIFT THE PATIENT'S LEG VIA THE REMOTE CONTROL, THE TOUCHSCREEN OF THE REMOTE CONTROL STOPPED WORKING. THE STAFF CONNECTED CORD TO THE HAND CONTROL, HOWEVER, IT DID NOT RESOLVE THE ISSUE. THE DIFFERENT HAND CONTROL WAS BROUGHT FROM ANOTHER OPERATING ROOM. THE ISSUE LED TO A SHORT DELAY OF APPROXIMATELY 15 MINUTES. THERE WAS NO INJURY REPORTED, HOWEVER, 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 16680409 ↗
• MalfunctionMar 28, 2023Unexpected Shutdown; Unexpected Shutdown

  ON 13TH MARCH 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES ¿ 100925A0 - UNIVERSAL REMOTE CONTROL USED WITH 116001B0 - OTESUS OR TABLE COLUMN, STATIONARY AND 116010A0 - UNIVERSAL TABLE TOP, IPC, EU. AS IT WAS STATED, DURING CHOLECYSTECTOMY, THE TOUCHSCREEN OF THE REMOTE CONTROL STOPPED WORKING. THE STAFF USED THE OVERRIDE PANEL AS A TEMPORARY SOLUTION. THE ISSUE LED TO A DELAY OF AROUND 5 MINUTES. THERE WAS NO INJURY OF THE PATIENT REPORTED, HOWEVER, 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 16628708 ↗