ORT200 TableRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00857534006349), received between Feb 3, 2022 and Oct 24, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (11 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-3033-2026 · 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-2584-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Difficult or Delayed Positioning; Failure to Align; Difficult or Delayed Positioning; Failure to Align

  DURING THE ONE(1) YEAR PREVENTATIVE MAINTENANCE (PM), THE MANUFACTURER'S FIELD SERVICE ENGINEER REPORTED THE ROTATIONAL LOCK ON THE ORT200 OPERATING ROOM TABLE WAS STRUGGLING TO OBTAIN THE LOCK STATUS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383734 ↗
• MalfunctionSep 5, 2024Difficult or Delayed Positioning; Unintended Movement; Difficult or Delayed Positioning; Unintended Movement

  THE CUSTOMER REPORTED THE ORT200 OPERATING ROOM TABLE'S ROTATIONAL LOCKING MECHANISM WAS INTERMITTENTLY FAILING TO LOCK TABLE ROTATION IN PLACE OR TO UNLOCK TO ALLOW TABLE ROTATION. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148313 ↗
• MalfunctionMay 23, 2024Unintended Movement; Unintended Movement

  THE CUSTOMER REPORTED THE ROTATIONAL LOCK OF THE ORT200 FAILED TO LOCK TABLE MOVEMENT IN PLACE AFTER BEING UNLOCKED AND ROTATED. THIS OCCURRED AFTER TERMINAL CLEANING AFTER A CASE AND IN PREPARATION FOR REMOVING THE TABLE WITH THE TABLE CART. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388844 ↗
• MalfunctionAug 18, 2023Difficult or Delayed Positioning; Unintended Movement; Difficult or Delayed Positioning; Unintended Movement

  THE CUSTOMER REPORTED THAT DURING SET-UP OF A NON-IMAGING CASE, THE OPERATING ROOM TABLE'S ROTATIONAL LOCKING MECHANISM FAILED TO UNLOCK TABLE MOVEMENT UNTIL SEVERAL ATTEMPTS WERE MADE. AFTER THE TABLE UNLOCKED ROTATIONAL POSITION AND THE TABLE WAS ROTATED TO THE DESIRED POSITION, THE MECHANISM SUBSEQUENTLY FAILED TO LOCK TABLE MOVEMENT UNTIL AFTER SEVERAL ATTEMPTS WERE MADE. THE CUSTOMER REPORTED THERE WAS A PATIENT ON THE TABLE DURING THE EVENT, AND THAT NO HARM OR IMPACT TO THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE INTERMITTENT MECHANISM FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577709 ↗
• MalfunctionApr 20, 2023Unintended Movement; Unintended Movement

  THE CUSTOMER REPORTED THAT DURING A MORNING QUALITY ASSURANCE / FUNCTIONAL CHECK, THE OPERATING ROOM TABLE'S ROTATIONAL LOCKING MECHANISM DID FUNCTION PROPERLY TO LOCK TABLE POSITION IN PLACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778977 ↗
• MalfunctionDec 21, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A QUALITY ASSURANCE/FUNCTIONAL CHECK, THE ORT200 ROTATIONAL LOCKING MECHANISM WOULD NOT LOCK THE TABLE POSITION INTO PLACE. NO PATIENT WAS INVOLVED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16031045 ↗
• MalfunctionFeb 7, 2022Unintended Movement; Unintended Movement

  DURING A SURGICAL PROCEDURE ON (B)(6) 2019, THE ORT200 TABLE DRIFTED DOWNWARD IN THE TRENDELENBURG FUNCTION WHILE THE PATIENT WAS ON THE TABLE. THERE WERE NO INJURIES REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476415 ↗
• MalfunctionFeb 7, 2022Unintended Movement; Unintended Movement

  DURING A CLEAR POINT PROCEDURE ON (B)(6), 2018, THE CUSTOMER REPORTED THAT THE ORT200 TABLE DRIFTED IN THE TRENDELENBURG POSITION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475732 ↗
• MalfunctionFeb 4, 2022Unintended Movement; Unintended Movement

  DURING A 14-HOUR ABLATION PROCEDURE ON (B)(6) 2021, THE CUSTOMER OBSERVED THAT THE ORT200 TABLE EXHIBITED SOME DRIFT.THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451188 ↗
• MalfunctionFeb 3, 2022Unintended Movement; Unintended Movement

  DURING A MONTERIS PROCEDURE ON (B)(6) 2020, THE ORT200 TABLE DRIFTED APPROXIMATELY 5MM IN THE TILT FUNCTION. THERE WAS NO PATIENT HARM REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446251 ↗
• MalfunctionFeb 3, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT THE ORT200 TABLE ROTATION WAS NOT LOCKING OR UNLOCKING.THE EVENT WAS OBSERVED DURING DAILY QA TESTING AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441687 ↗
• MalfunctionFeb 3, 2022Unintended Movement; Unintended Movement

  ON (B)(6) 2019, THE CUSTOMER REPORTED THAT THE ROTATIONAL LOCK ON THE ORT200 FAILED TO LOCK.THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441384 ↗