Recall Z-3033-2026— IMRIS Imaging Inc
Class II · Ongoing
Class II FDA medical device recall by IMRIS Imaging Inc, initiated 2026-08-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- IMRIS Imaging Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-06
- Firm location
- Chaska, MN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.