Device recall
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
- Recall number
- Z-3034-2026
- 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
- KXJ
- Device type
- Table, Radiologic
- 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
- 13 units
- Code info
- 114093-000 - UDI-DI: 00857534006356, Serial Numbers: 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119; 114093-600 - UDI-DI: 00857534006462, Serial Numbers: 10002996, 10004515, 10007411, 10007376
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Chaska, MN, United States