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ORT100 Table (UDI 00857534006486)Recalls & reported problems

IMRIS Imaging, Inc. · T2X OR Table V.2, 110470-600 · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857534006486), received between Feb 9, 2022 and Feb 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

    ON (B)(6) 2019, THE CUSTOMER REPORTED A HYDRAULIC FLUID LEAK IN THE ORT100 TABLE. THE EVENT OCCURRED DURING DAILY QA TEST AND THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13501162 ↗

Other Table, Operating-Room, Ac-Powered devices

All Table, Operating-Room, Ac-Powered devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.