Z-3033-2026 Class II Ongoing
FDA device recall Z-3033-2026 was initiated by IMRIS Imaging Inc on August 6, 2026 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- August 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
Code Information
113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997