ORT300 Table (UDI 00857534006356)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00857534006356), received between Feb 2, 2022 and Jan 29, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).

2 FDA recall records 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. 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 · 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-2585-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, 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 ↗
• 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 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, 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 ↗
• MalfunctionFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING ROUTINE PREVENTIVE MAINTENANCE ON NOVEMBER 8, 2019, AN IMRIS SERVICE ENGINEER OBSERVED A SMALL SEEPAGE LEAK IN THE HYDRAULIC LINE TO THE BACK TILT CYLINDER IN THE ORT300 TABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476178 ↗
• MalfunctionFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING ROUTINE PREVENTIVE MAINTENANCE ON JULY 23, 2019, AN IMRIS SERVICE ENGINEER OBSERVED A HYDRAULIC FLUID LEAK FROM A FLOW CONTROL VALVE IN THE ORT300 OPERATING ROOM TABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476047 ↗
• MalfunctionFeb 7, 2022Unintended Movement; Unintended Movement

  ON MARCH 12, 2019, AN IMRIS CUSTOMER SERVICE ENGINEER REPORTED THAT THE ORT300 TABLE EXHIBITED SOME DRIFT IN THE ROLL POSITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475873 ↗
• MalfunctionFeb 7, 2022Break; Break

  ON (B)(6) 2018, A CUSTOMER SERVICE ENGINEER (CSE) REPAIRED THE FLOOR LATCH OF AN ORT300 TABLE. IN ADDITION, THE CSE INSPECTED THE ROTATIONAL LOCK MECHANISM OF THE TABLE AND DISCOVERED A BROKEN PIN. THE BROKEN PIN DID NOT ALLOW THE TABLE TO LOCK IN THE ROTATIONAL FUNCTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475757 ↗
• MalfunctionFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE ORT300 TABLE EXHIBITED A HYDRAULIC FLUID LEAK. THIS WAS OBSERVED DURING DAILY QA AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475684 ↗
• MalfunctionFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER SERVICE ENGINEER OBSERVED A SMALL LEAK IN THE HYDRAULIC PRESSURE HOSE IN THE ORT300 TABLE DURING A PLANNED MAINTENANCE CHECK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475583 ↗
• MalfunctionFeb 6, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THE ORT300 OPERATING ROOM TABLE FAILED TO LOCK INTO PLACE, WAS NON-FUNCTIONAL, WHILE IN USE. NO PATIENT IMPACT OR PROCEDURAL CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467544 ↗
• MalfunctionFeb 4, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2020, THE CUSTOMER REPORTED THAT THE ROTATIONAL LOCK ON THE ORT300 TABLE WAS NOT ENGAGING OR LOCKING. THE EVENT WAS OBSERVED DURING DAILY QA AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453385 ↗
• MalfunctionFeb 4, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2021, THE CUSTOMER REPORTED THAT THE ROTATIONAL LOCK ON THE ORT300 TABLE WILL NOT LOCK. THE EVENT WAS OBSERVED DURING DAILY QA AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451195 ↗
• MalfunctionFeb 3, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2020, THE CUSTOMER REPORTED THAT THE ORT300 WAS DRIFTING. THE EVENT OCCURRED DURING PROCEDURE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446200 ↗
• MalfunctionFeb 2, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT THE ORT300 TABLE DRIFTED IN THE ROLL POSITION DURING A PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425810 ↗