Imris Imaging Inc: Table, Operating-room, Ac-powered
Recall Summary IMRIS Imaging Inc is recalling ORT200 operating room tables due to a mechanical failure in the linear actuator and rotational lock mechanism that may prevent the table from properly locking or unlocking. If the table unlocks unintentionally during surgery, it could cause patient injury from unexpected movement. The affected tables were distributed nationwide in the US and internationally in Canada, China, Japan, and Sweden.
- Recalling firm
- 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 I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-06
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/04689d2f-be4b-4acb-b53d-0720cd54ca97