Beijing Syntech Laser Co., Ltd recalls Beijing Syntech Laser UL Station surgical lasers

Recall date

July 3, 2017

Source

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

Recall number

Z-1495-2018

FDA classification

Class II

Brand / firm

Beijing Syntech Laser Co., Ltd

Sold / distributed

US Distribution

Why it was recalled

The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Beijing Syntech Laser UL Station surgical lasers