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)
FDA Recall Z-2448-2015 · Posted 2015-08-21
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Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeHRM
Date Initiated2015-08-11
Date Terminated2016-11-04
Product Quantity688 units
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.
Firm Action
Alcon sent an Urgent Medical Device Correction letter dated August 11, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Alcon at 800-862-5266.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, France, Germany, Greece, Guatemala, Hungary, India, Italy, Japan, Jordan, Korea, Lebanon, Malaysia, Mexico, Mongolia, New Zealand/Fiji, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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