Device recall
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
- Recall number
- Z-3033-2026
- Event id
- 99596
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- IMRIS Imaging Inc
- Report date
- Sep 2, 2026
- Posted
- Aug 26, 2026
- Initiated
- Aug 6, 2026
- Center classification date
- Aug 26, 2026
- Product code
- FQO
- Device type
- Table, Operating-Room, Ac-Powered
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 6 units
- Code info
- 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Chaska, MN, United States