Home / Recalls / Medical Devices
Beijing Syntech Laser Co., Ltd recalls Beijing Syntech Laser Diode Laser surgical lasers
Recalled May 9, 2018 · FDA recall Z-1488-2018 · Beijing Syntech Laser
Hazard
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". · FDA Class II
Units
13
Sold at
US Distribution
Description
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".
Product
Beijing Syntech Laser Diode Laser surgical lasers
Manufacturer(s)
Beijing Syntech Laser Co., Ltd
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →