Xintec Corp recalls OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot…

Recall date

October 29, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0162-2020

FDA classification

Class III

Brand / firm

Xintec Corp

Sold / distributed

PA and VA

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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