FDA recall Z-1490-2018

Product

Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers

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".

Distribution

US Distribution

Key facts

Status

Ongoing

Initiation date

2017-07-03

Report date

2018-05-09

Voluntary/Mandated

FDA Mandated

Location

Beijing, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2018