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Xintec Corp recalls OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot
Recalled October 30, 2019 · FDA recall Z-0162-2020 · Xintec
Hazard
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in. · FDA Class III
Units
45 lasers
Sold at
PA and VA
Description
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
Product
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
Manufacturer(s)
Xintec Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →