Beijing, N/A, China
Beijing Syntech Laser Co., Ltd recalls
1 recall recorded since 2018, most recently on 3 July 2017. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 July 2017
- Reason
- 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
- Initiated
- FDA Mandated
- Recall numbers
- Z-1493-2018, Z-1491-2018, Z-1488-2018, Z-1495-2018, Z-1492-2018, Z-1490-2018, Z-1494-2018, Z-1489-2018
- Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
- Beijing Syntech Laser UL C02 Laser surgical lasers
- Beijing Syntech Laser Diode Laser surgical lasers
- Beijing Syntech Laser UL Station surgical lasers
- Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
- Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
- Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
- Beijing Syntech Laser Trixel C02 Laser surgical lasers
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.