Z-2448-2015Class II

LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue

Name: Z-2448-2015 LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue
Creator: Alcon Research, Ltd.
Published: 2015-08-11
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2015-08-11 / Terminated / root cause: design

FDA source

Alcon Research, Ltd. began a recall of 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... on 2015-08-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2448-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-11
Posted: 2015-08-21
Terminated: 2016-11-04
Recalling firm: Alcon Laboratories
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)
Product code: HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: All units LX3 Microscope Floor Stands manufactured prior to July 2015 (Serial Numbers 1402548501X to 1502857606X)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2448-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2448-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-21

Product code HRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)