ORT300 Table (UDI 00857534006462)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00857534006462), received between Feb 7, 2022 and Dec 9, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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-2586-2021 · Root cause: Device Design · FDA record ↗

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.

• 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 ↗
• 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, 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, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018, THE CUSTOMER REPORTED THAT THERE WAS A HYDRAULIC OIL LEAK IN THE ORT300 TABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475587 ↗