Home / Recalls / Medical Devices
IMRIS Imaging Inc recalls ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the
Recalled September 2, 2026 · FDA recall Z-3033-2026 · IMRIS Imaging
Hazard
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. · FDA Class II
Units
6 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Description
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.
Product
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
Manufacturer(s)
IMRIS Imaging Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →