Class II — IMRIS Imaging Inc
| Recalling firm | IMRIS Imaging, Inc. |
|---|---|
| Registered facility | IMRIS Imaging, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 |
| Quantity | 6 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden. |
| Initiated | 2026-08-06 |
| Classified | 2026-08-26 |
| Recall number | Z-3033-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — IMRIS Imaging Inc (Z-3033-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99596/
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