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Lumenis, Inc. recalls Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular
Recalled September 18, 2013 · FDA recall Z-2191-2013 · Lumenis
Hazard
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user. · FDA Class II
Units
3 units
Sold at
Distributed in the states of NJ, PA, and IL.
Description
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Product
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Manufacturer(s)
Lumenis, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →