IMRIS Imaging Inc: 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

Is my product affected?

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

• UPC 00857534006349

Check against the official notice below — it lists the full affected range.

What happened

IMRIS Imaging Inc. is recalling six ORT200 operating room tables distributed worldwide, including in the US, Canada, China, Japan, and Sweden. The affected units are the ORT200 Covered Table Assembly (Part Number 113821-600, Serial Numbers 10003754 and 10006997) and the ORT200 50/60Hz Covered Table Assy V2 (Part Number 114148-000, Serial Numbers 10005189, 10005190, 10004463, and 10004997). The linear actuator and rotational lock mechanism components in these tables may experience mechanical failure that prevents the system from transitioning between locked and unlocked states.

This mechanical failure poses a risk of injury to patients if unintended rotational movement occurs during a surgical procedure. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: Worldwide distribution - US Nationwide and the countries of Canada, China, Japan, Sweden. Quantity: 6 units Lot/code info: 113821-600 - Serial Numbers: 10003754, 10006997; 114148-000 - UDI-DI: 00857534006349, Serial Numbers: 10005189, 10005190, 10004463, 10004997

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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