LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor S

FDA device recall Z-2448-2015 · posted 2015-08-21 · Terminated

Recall details

Recalling firm

Alcon Research, Ltd.

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.

Action taken

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

Status

Terminated

Product code

HRM

Quantity affected

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 Repub

Date initiated

2015-08-11

Date posted

2015-08-21

Date terminated

2016-11-04

Location

Fort Worth, TX