IMRIS Imaging Inc recalls ORT200
- Recalling company
- IMRIS Imaging Inc
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 6, 2026
- Reported
- Sep 2, 2026
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Status
- Ongoing
- Quantity
- 6 units
- Lot / codes
- 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
- Company location
- Chaska, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3033-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3033-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.