ORT200 113821-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00857534006738), received between Jan 19, 2021 and Sep 13, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (3 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 25, 2021Class IITerminated

   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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Unintended Movement; Unintended Movement

  CUSTOMER REPORTED THAT DURING A LASER ABLATION PROCEDURE, MONTERIS STAFF AND CUSTOMER STAFF NOTICED THE INITIAL PROBE SCAN AND POST ABLATION SCANS DO NOT ALIGN, INDICATING SUSPECTED OPERATING ROOM TABLE DRIFT. IT WAS REPORTED NO ADDITIONAL MEDICATIONS, MONITORING OR UNPLANNED PROCEDURAL STEPS WERE REQUIRED AND THE PROCEDURE WAS SUCCESSFUL. THIS MDR IS BEING SUBMITTED BASED ON MANUFACTURER AWARENESS OF A SECOND CASE IN WHICH THE ALLEGED TABLE DRIFT OCCURRED AS CAPTURED IN MDR 3010326005-2024-00010.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218564 ↗
• MalfunctionJun 23, 2023Unintended Movement; Unintended Movement

  THE CUSTOMER REPORTED THAT DURING THE SET-UP PHASE OF A SURGICAL PROCEDURE THE IMRIS ORT200 OPERATING ROOM TABLE WOULD NOT LOCK INTO POSITION AFTER IT WAS UNLOCKED FOR ROTATION. THIS CAUSED A DELAY IN THE START TIME OF THE PROCEDURE AND A PATIENT WAS ON THE TABLE AT THE TIME OF THE EVENT. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE NON-IMRIS OPERATING ROOM TABLE THAT WAS BROUGHT INTO THE OPERATING ROOM. THE CUSTOMER REPORTED INTERRUPTION TO WORKFLOW AND ADDITIONAL TIME UNDER ANESTHESIA FOR THE PATIENT, AND THAT THE CASE WAS COMPLETED AS INTENDED. NO FURTHER PATIENT OR PROCEDURAL COMPLICATIONS WERE REPORTED. NO INTRA-OPERATIVE IMAGING WAS PLANNED FOR THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192251 ↗
• MalfunctionFeb 6, 2023Unintended Movement; Unintended Movement

  THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY UNLOCKED THE ROTATIONAL LOCK OF THE ORT DURING A SURGICAL CASE AND COULD NOT GET THE TABLE TO LOCK BACK IN PLACE AFTER ROTATION TO THE NEW POSITION. THE ONGOING PROCEDURE WAS A DRAINAGE FOR A BRAIN ABCESS; IMAGING WAS NOT SCHEDULED, PLANNED OR REQUESTED. THE REPORTER INDICATED THERE WAS NO DELAY IN THE CASE OR ADDITIONAL TIME REQUIRED TO COMPLETE THE PROCEDURE, AND NO IMPACT TO THE PATIENT. THE PHYSICIAN ELECTED TO SECURE THE PATIENT WITH STRAPS AND CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308061 ↗
• MalfunctionJun 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THEY OBSERVED HYDRAULIC FLUID ON THE OPERATING ROOM TABLE COVERS. NO PATIENT INVOLVEMENT OR MALFUNCTION IN THE TABLE'S OPERATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739259 ↗
• MalfunctionJan 19, 2021Unintended System Motion; Decrease in Pressure; Unintended System Motion; Decrease in Pressure

  OPERATING ROOM STAFF NOTICED THAT OVER THE WEEKEND AND LONG HOLIDAY, THE ORT200 TABLE HAD DRIFTED HEAD UPWARDS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195368 ↗