Class IIDeviceOngoing

IMRIS Imaging Inc

ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600

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-3034-2026
Event ID: 99596
Recall initiated: Aug 6, 2026
Classified: Aug 26, 2026
Reported: Sep 2, 2026
Quantity: 13 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: 114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376