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U.S. Department of Health and Human Services

Class 2 Device Recall LX3 Microscope Floor Stand

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  Class 2 Device Recall LX3 Microscope Floor Stand see related information
Date Initiated by Firm August 11, 2015
Date Posted August 21, 2015
Recall Status1 Terminated 3 on November 04, 2016
Recall Number Z-2448-2015
Recall Event ID 71941
Product Classification Microscope, operating & accessories, ac-powered, ophthalmic - Product Code HRM
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)
Code Information All units LX3 Microscope Floor Stands manufactured prior to July 2015 (Serial Numbers 1402548501X to 1502857606X)
Recalling Firm/
Manufacturer		 Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Alcon Customer Service
800-862-5266
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 688 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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