ORT300 recall (IMRIS Imaging Inc)
Medical deviceClass IIOngoing
Summary: IMRIS Imaging Inc is recalling ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600. Reason: 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.
What is being recalled
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3034-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 6, 2026 |
| Reported | September 2, 2026 |
| Company | IMRIS Imaging Inc |
| Company location | Chaska, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 13 units |
More recalls from IMRIS Imaging Inc · all medical device recalls · recalls from August 2026