FDAFDA recall Z-3033-2026 · Sep 2, 2026
IMRIS Imaging Inc: ORT200 recall
Recall found
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 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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
- Quantity
- 6 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Recalling firm
- IMRIS Imaging Inc, Chaska, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-06
Source: openFDA enforcement record Z-3033-2026 · search recall number Z-3033-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.