Beijing Syntech Laser Co., Ltd: Medical Device Recall in 2018 - (Recall #: Z-1491-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Beijing Syntech Laser UL C02 Laser surgical lasers

Product Classification:

Class II

Date Initiated: July 3, 2017

Date Posted: May 9, 2018

Recall Number: Z-1491-2018

Event ID: 79697

Reason for Recall:

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".

Status: Ongoing

Product Quantity: 92

Code Information:

Model UL C02 Laser

Distribution Pattern:

US Distribution

Voluntary or Mandated:

FDA Mandated