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Laserex Systems Inc. recalls Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective
Recalled June 14, 2017 · FDA recall Z-2172-2017 · Laserex Systems
Hazard
It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient. · FDA Class II
Units
83
Sold at
US Distribution
Description
It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient.
Product
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.
Manufacturer(s)
Laserex Systems Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →