IMRIS Imaging Inc: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Cove
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
- Recall initiated
- 2026-08-06
- Code info
- 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997
- Product quantity
- 6 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Chaska
- State
- MN
- Country
- United States
- Event id
- 99596
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