United StatesORT200 and ORT300 operating room tables are affected, including ORT200 Covered Table Assembly, Reconditioned (Part 113821-600; SN 10003754, 10006997), ORT200 50/60Hz Covered Table Assy V2 (Part 114148-000; UDI‑DI 00857534006349; SN 10005189, 10005190, 10004463, 10004997), ORT300 Modular Table Main Unit Assy (Part 114093-000; UDI‑DI 00857534006356; SN 10005695, 10002998, 10002997, 10005456, 10005612, 10004372, 10005613, 10002841, 10011119) and 114093-600 (UDI‑DI 00857534006462; SN 10002996, 10004515, 10007411, 10007376). They were recalled because the linear actuator and rotational lock mechanism may mechanically fail, preventing transition between locked and unlocked states and risking unintended rotational movement that could injure a patient.
What's being recalled
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
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Recalling firm: IMRIS Imaging Inc, Chaska, MN, United States.
How to identify it
113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997 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
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)