ORT100 Table (UDI 00857534006332)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00857534006332), received between Aug 29, 2021 and Jul 8, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT ON (B)(6) 2022 THE HEAD END OF AN ORT T2X OPERATING ROOM TABLE DRIFTED APPROXIMATELY 6MM DOWNWARD DURING A CASE. THE DRIFT WAS OBSERVED THROUGH A NAVIGATION SYSTEM IN USE DURING THE CASE. NO PATIENT OR PROCEDURAL IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957930 ↗
• MalfunctionJun 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, DURING PREVENTIVE MAINTENANCE AN IMRIS CUSTOMER SERVICE ENINGINEER OBSERVED A SMALL LEAK OF HYDRAULIC FLUID IN THE WALL MOUNTED CONTROL PANEL OF THE T2X OPERATING ROOM TABLE. THERE WAS NO PATIENT INVOLVEMENT AND THE TABLE PASSED FUNCTIONAL TESTING DURING THE PREVENTIVE MAINTENANCE SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14805692 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AN O-RING WAS REQUIRED AT SITE. UPON ARRIVAL ON-SITE, AN IMRIS SERVICE ENGINEER DETERMINED THAT THE ORT TABLE HYDRAULIC PUMP EXHIBITED A SMALL LEAK HOWEVER; THE LEAK DID NOT AFFECT THE FUNCTION OF THE TABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509885 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING ROUTINE PREVENTIVE MAINTENANCE, AN IMRIS SERVICE ENGINEER FOUND AN EXTREMELY SLOW LEAK IN THE HYDRAULIC HOSE OF THE ORT100 OPERATIONG ROOM TABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508574 ↗
• MalfunctionFeb 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PLANNED MAINTENANCE ON (B)(6), 2019, AN IMRIS SERVICE ENGINEER OBSERVED A SMALL HYDRAULIC FLUID LEAK AT THE ORT100 TABLE PUMP/RESERVOIR. THE LEAK DID NOT AFFECT THE TABLE FUNCTION AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501157 ↗
• MalfunctionFeb 9, 2022Fluid/Blood Leak; Unintended Movement; Fluid/Blood Leak; Unintended Movement

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT THE ORT100 TABLE IS DRIFTING VERY SLOWLY WITHOUT ANY WEIGHT ON IT. THE EVENT OCCURRED DURING DAILY QA TEST AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501128 ↗
• MalfunctionFeb 3, 2022Mechanical Jam; Mechanical Jam

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT THE ORT100 TABLE FOOT PEDAL WAS VERY DIFFICULT FOR LOCKING AND UNLOCKING THE TABLE ROTATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441873 ↗
• MalfunctionFeb 2, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2018, AN ORT100 TABLE WAS USED TO PERFORM A PROCEDURE ON A PATIENT IN A LATERAL POSITION. THE PATIENT'S BODY WAS VERY CLOSE TO THE EDGE OF THE TABLE AND WAS SECURED TO THE TABLE WITH LARGE ROLLS OF TAPE. THE NURSE PROCEEDED TO SCAN THE PATIENT AND NOTICED THE TABLE WAS TIPPED AT AN ANGLE AWAY FROM THE DOORS OF THE SUITE. THE NURSE PRESUMED THAT THE SURGEON HAD REQUESTED THE ANGLED POSITION. THE NURSE FLATTENED THE TABLE AND CONTINUED TO SCAN THE PATIENT HOWEVER;THE IMAGES WERE POOR BECAUSE IT APPEARED AS IF THE PATIENT WAS MOVING DURING THE SCAN. UPON RETURNING TO MOVE THE SCANNER OFF THE PATIENT, THE ANESTHETIST AND THE NURSE NOTICED THAT THE TABLE HAD TILTED AGAIN TOWARDS THE SIDE WHERE THE MAJORITY OF THE PATIENT'S WEIGHT WAS LOCATED. THERE WAS NO PATIENT INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13428236 ↗
• MalfunctionFeb 2, 2022Mechanical Jam; Mechanical Jam

  ON (B)(6) 2018, THE CUSTOMER REPORTED THAT THE LOCKING MECHANISM ON THE ORT100 TABLE WAS NOT LOCKING OR UNLOCKING.THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425571 ↗
• MalfunctionFeb 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER SERVICE ENGINEER OBSERVED A HYDRAULIC FLUID LEAK IN ONE PTFE HOSE INSIDE THE ORT100 TABLE CONTROL PANEL IN OR2.THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424905 ↗
• MalfunctionFeb 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER SERVICE ENGINEER OBSERVED A HYDRAULIC FLUID LEAK IN ONE PTFE HOSE INSIDE THE ORT100 TABLE CONTROL PANEL IN OR1. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418953 ↗
• MalfunctionJan 8, 2022Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THE ROTATIONAL LOCKING MECHANISM IN AN ORT100 OPERATING ROOM TABLE WAS JAMMED, SUCH THAT IT WOULD NOT LOCK OR UNLOCK. THE ROTATIONAL LOCK IS CONTROLLED THROUGH USE OF A FOOT PEDAL, WHICH WAS DIFFICULT TO DEPRESS AND MECHANICALLY ENGAGE THE ROTATIONAL LOCKING MECHANISM. NO PATIENT INVOLVEMENT WAS REPORTED, THE ISSUE WAS OBSERVED DURING A QA CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13200899 ↗
• MalfunctionAug 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE OPERATING ROOM TABLE WAS REPORTED TO BE LEAKING HYDRAULIC FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381679 ↗