FDA recall Z-1493-2018

Beijing Syntech Laser Co., Ltd · Class II · device

Product

Beijing Syntech Laser APOLLO JV+ Medical Platform 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-1493-2018