Recall Z-2448-2015— Alcon Research, Ltd.
Class II · Terminated
Class II FDA medical device recall by Alcon Research, Ltd., initiated 2015-08-11, terminated 2016-11-04. FDA's recall record names no specific 510(k) clearance for this event. Product: LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers). Reason: Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure..
- Recalling firm
- Alcon Research, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-11
- Terminated
- 2016-11-04
- Firm location
- Fort Worth, TX, United States
Product description
LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers)
Reason for recall
Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.