Imris Imaging Inc: Ort200, Operating Room Table, Including The Ort200 Covered Table Assembly, Reconditioned, Part Number 113821-600 And The Ort200 50/60hz Covered Tab...
IMRIS Imaging Inc. is recalling certain ORT200 operating room tables because mechanical components that lock and unlock the table may fail, potentially allowing unintended movement during surgery. The recall affects reconditioned tables with specific part numbers that were distributed worldwide, including throughout the United States and in Canada, China, Japan, and Sweden. This is a Class II recall, indicating a potential risk of injury to patients.
- 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 II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-06
- Status
- Ongoing
- 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 U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/61d5bbb7-263b-4440-9b89-aa7b7ac38e3a