Class IIDeviceOngoing

IMRIS Imaging Inc

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

Reason for recall

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.

Details

Recall number: Z-3033-2026
Event ID: 99596
Recall initiated: Aug 6, 2026
Classified: Aug 26, 2026
Reported: Sep 2, 2026
Quantity: 6 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Initiated by: Voluntary: Firm initiated
Firm notification: N/A
Firm location: Chaska, MN, United States
Lot / code info: 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997