Alcon Recalls LX3 Microscope Floor Stands Due to Cabling Issues
Alcon is voluntarily recalling LX3 Microscope Floor Stands because cabling issues may cause loss of functionality or illumination failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a functional defect (loss of functionality/illumination) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Alcon Research, Ltd. is initiating a voluntary recall of 688 units of the LX3 Microscope Floor Stand. This accessory is used with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization to provide a portable suspension system for the microscope.
The recall is being conducted after reports indicated that cabling issues between the power, host, and illumination modules could cause a loss of functionality. These issues may result in the system displaying a system message and/or causing an illumination failure.
The affected units are all LX3 Microscope Floor Stands manufactured prior to July 2015, with serial numbers ranging from 1402548501X to 1502857606X. These products were distributed worldwide, including in the United States and numerous international locations. Users should contact Alcon for further instructions regarding the recall.
The recalled product
- 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…
- Manufacturer
- Alcon Research, Ltd.
- Hazard
- Affected units
- 688
Distribution
Distributed nationwide across the United States.
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