Official recall notice
FDA DeviceClass IINotable
FDA Recall: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Numbe
- 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
113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997