Imris Imaging Inc: Table, Radiologic
Recall Summary IMRIS Imaging Inc is recalling ORT300 operating room tables with certain serial numbers due to a mechanical failure in the locking mechanism that could allow unintended rotation during surgical procedures, potentially injuring patients. The affected tables were distributed nationwide in the US and internationally to Canada, China, Japan, and Sweden. This is a Class II recall affecting the table's linear actuator and rotational lock components.
- Recalling firm
- IMRIS Imaging Inc
- Product
- ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
- 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
- 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/32f886cf-809f-448f-85e7-ea0880b39be8