ORT300 TableRecalls & reported problems across all models

We found 2 models of ORT300 Table by IMRIS Imaging, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2022 and Jan 29, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 reports).

3 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ORT300 Table recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 6, 2026Open, Classified

   The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.

   Z-3034-2026 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

2. Aug 25, 2021Terminated

   ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

   Z-2586-2021 · Root cause: Device Design · Recall details · FDA record ↗

3. Aug 25, 2021Terminated

   ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.

   Z-2585-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported ORT300 Table problems

ORT300 Table models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ORT300 Table

  Table, Operating-Room, Ac-Powered
  2 recalls21 reports
• ORT300 Table

  Table, Radiologic
  2 recalls6 reports

Recent ORT300 Table adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Fluid/Blood Leak

  THE IMRIS CUSTOMER SERVICE ENGINEER (CSE) NOTICED A SMALL HYDRAULIC LEAK COMING FROM THE HEIGHT VALVE ASSEMBLY DURING THE PREVENTATIVE MAINTENANCE (PM) OF THE ORT300 OPERATING ROOM TABLE. THERE WERE ALSO HYDRAULIC SPOTS NOTED AT THE TREND FLOW VALVE LOCATION. NO TABLE FUNCTIONAL ISSUES WERE IDENTIFIED OR REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215373 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  THE CUSTOMER NOTIFIED IMRIS CUSTOMER SERVICE ENGINEER VIA EMAIL, STATING THEY HAD OBSERVED OIL COMING FROM THE ORT300 OPERATING ROOM TABLE. THE IMRIS CSE INSPECTED THE TABLE AND IDENTIFIED SMALL AMOUNTS OF HYDRAULIC FLUID LEAKING FROM THE UNPRESSURIZED FLUID RESERVOIR AND FROM MULTIPLE VALVES WITHIN THE PRESSURIZED HYDRAULIC CONTROL SYSTEM. NO TABLE FUNCTIONAL ISSUES WERE IDENTIFIED OR REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597673 ↗
• MalfunctionJan 17, 2025Unintended Movement; Unintended Movement

  THE CUSTOMER REPORTED THAT DURING OPERATING ROOM PREPARATION, THEY WERE NOT ABLE TO LOCK THE ROTATIONAL POSITION OF THE ORT300 REMOVABLE OPERATING ROOM TABLE. THERE WAS NO PATIENT INVOLVEMENT. AN ALTERNATE ORT300 REMOVABLE OPERATING ROOM TABLE WAS UTILIZED IN THE SUBSEQUENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185499 ↗
• MalfunctionNov 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A BIOMEDICAL TECHNICIAN AT THE CUSTOMER SITE REPORTED OBSERVING HYDRAULIC FLUID AT THE BASE OF THE ORT300 OPERATING ROOM TABLE. THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT AT THE TIME OF THE OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088480 ↗
• MalfunctionOct 26, 2023Unintended Movement; Unintended Movement

  THE CUSTOMER REPORTED THEY WERE NOT ABLE TO LOCK THE ROTATIONAL POSITION IN THE ORT300 OPERATING ROOM TABLE. THIS OCCURRED DURING EQUIPMENT CLEANING AND HAD NO PROCEDURAL OR PATIENT INVOLVMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016906 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  DURING ROUTINE PREVENTIVE MAINTENANCE, AN IMRIS CUSTOMER SERVICE ENGINEER OBSERVED DROPS OF HYDRAULIC FLUID OUTSIDE OF THE HYDRAULIC LINES OF THE ORT300 OPERATING ROOM TABLE. THE SOURCE OF THE LEAK WAS TRACED TO A FITTING ON A PRESSURIZED HYDRAULIC LINE. NO TABLE FUNCTIONAL ISSUES WERE IDENTIFIED DURING SUBSEQUENT TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375352 ↗
• MalfunctionDec 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING ROUTINE PREVENTIVE MAINTENANCE, AN IMRIS SERVICE ENGINEER OBSERVED LEAKAGE OF HYDRAULIC FLUID FROM A PTFE HOSE UNION WITHIN THE OPERATING ROOM TABLE. NO TABLE FUNCTIONAL ISSUES WERE OBSERVED AND NO REPORTS HAVE BEEN RECEIVED FROM THE CUSTOMER RELATING TO THE FLUID LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955521 ↗
• MalfunctionNov 30, 2022Unintended Movement; Unintended Movement

  THE CUSTOMER REPORTED THAT DURING THEIR MORNING QUALITY ASSURANCE / FUNCTIONAL CHECK, THE ORT300 ROTATIONAL LOCKING MECHANISM WOULD NOT LOCK THE TABLE POSITION INTO PLACE. NO PATIENT WAS INVOLVED AT THE TIME; THE CUSTOMER REPORTED AN UPCOMING CASE PLANNED FOR THE OPERATING ROOM IN WHICH THE ISSUE OCCURRED WAS MOVED INTO THE ADJACENT OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890744 ↗
• MalfunctionAug 29, 2022Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  DURING ROUTINE PREVENTIVE MAINTENANCE, AN IMRIS CUSTOMER SERVICE ENGINEER OBSERVED SEVERAL SMALL DROPS OF HYDRAULIC FLUID ON OUTSIDE OF THE HYDRAULIC LINES OF THE ORT300 OPERATING ROOM TABLE. NO ISSUES WERE REPORTED OR OBSERVED WITH RESPECT TO HYDRAULICS CONTROLLED TABLE FUNCTIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316924 ↗
• MalfunctionJul 21, 2022Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  A CUSTOMER REPORTED THAT DURING A MORNING QA, DROPS OF HYDRAULIC FLUID WERE OBSERVED AT THE BASE OF THE ORT300 OPERATING ROOM TABLE. NO ISSUES WERE REPORTED WITH RESPECT TO HYDRAULICS CONTROLLED TABLE FUNCTIONS. THERE WAS NO PATIENT INVOLVEMENT WHEN THE APPARENT LEAK WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080468 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT HYDRAULIC FLUID LEAKS OCCURED DAILY AND DURING SURGERY FROM THE ORT300 TABLE. APPROXIMATELY 4CM IN DIAMETER OF PUDDLE FLUID LEAK OCCURRED HOWEVER; THE LEAK DID NOT AFFECT THE FUNCTION OF THE TABLE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507186 ↗
• MalfunctionFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018, THE CUSTOMER REPORTED THAT THE TABLE WAS EXHIBITING A SIGNIFICANT HYDRAULIC FLUID LEAK. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476411 ↗
• MalfunctionFeb 7, 2022Unintended Movement; Unintended Movement

  ON (B)(6), 2019, THE CUSTOMER REPORTED THAT THE ORT300 TABLE DRIFTED LEFT. THE EVENT OCCURRED DURING DAILY QA AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476405 ↗
• MalfunctionFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN OPEN BRAIN TUMOR PROCEDURE ON (B)(6) 2019, THE ORT300 OPERATING ROOM TABLE DRIFTED IN THE LEFT ROLL POSITION AT APPROXIMATELY 8-10 DEGREES. THERE WAS A 20 MINUTE DELAY IN THE CASE WHILE THE OPERATING ROOM (OR) STAFF ATTEMPTED TO FIT THE PATIENT INTO THE SCANNER WITHOUT COMPROMISING THE FIELD OR PATIENT POSITION. THE OPERATING ROOM STAFF WAS ABLE TO COUNTERBALANCE THE ROLL MOVEMENT WITH TWO PEOPLE LEANING ON THE RIGHT SIDE OF THE OR TABLE TO KEEP IT LEVELED WHILE THE MAGNET MOVED OVER THE PATIENT. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476371 ↗
• MalfunctionFeb 7, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT THE ORT300 OPERATING ROOM TABLE WAS MOVING UNDER PRESSURE.THE EVENT OCCURRED DURING DAILY QA AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476204 ↗

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