Official recall notice
FDA Recall: ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093
- Recall date
- 2026-09-02
- Brand
- IMRIS Imaging Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product 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.
Affected products
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