Home / Recalls / Beijing Syntech Laser Co., Ltd / Z-1488-2018

Z-1488-2018 Class II Ongoing

Recalled by Beijing Syntech Laser Co., Ltd — Beijing, N/A

Recall Details

Product Type
Devices
Report Date
May 9, 2018
Initiation Date
July 3, 2017
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
13

Product Description

Beijing Syntech Laser Diode 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 Pattern

US Distribution

Code Information

Model Diode Laser

Other recalls by Beijing Syntech Laser Co., Ltd

  • Z-1490-2018 Class II — Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers (July 3, 2017)
  • Z-1495-2018 Class II — Beijing Syntech Laser UL Station surgical lasers (July 3, 2017)
  • Z-1493-2018 Class II — Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers (July 3, 2017)
  • Z-1494-2018 Class II — Beijing Syntech Laser Nice Station Light Based Platform surgical lasers (July 3, 2017)
  • Z-1489-2018 Class II — Beijing Syntech Laser Trixel C02 Laser surgical lasers (July 3, 2017)
  • Z-1492-2018 Class II — Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers (July 3, 2017)
  • Z-1491-2018 Class II — Beijing Syntech Laser UL C02 Laser surgical lasers (July 3, 2017)