FDA (Devices) recall action 79697
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
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".
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Beijing Syntech Laser Co., Ltd is recalling 11 APOLLO V+ Medical Platform surgical lasers because the required certification label was not affixed to the product.
Beijing Syntech Laser Co., Ltd is recalling three Trixel 11 CO2 surgical lasers because the required certification label was not affixed to the products.
Beijing Syntech Laser Co., Ltd is recalling 92 UL C02 Laser surgical lasers because the required certification label was not affixed to the product.
Beijing Syntech Laser Co., Ltd is recalling 13 Diode Laser surgical lasers because the required certification label was not affixed to the products.
Beijing Syntech Laser is recalling six APOLLO JV+ Medical Platform surgical lasers because the required certification label was not affixed to the products.
Beijing Syntech Laser Co., Ltd is recalling 38 Trixel C02 Laser surgical lasers because the required certification label was not affixed to the product.
Beijing Syntech Laser Co., Ltd is recalling 199 UL Station surgical lasers because the required laser safety certification label was not affixed to the product.
Beijing Syntech Laser Co., Ltd is recalling seven Nice Station Light Based Platform surgical lasers because the required laser safety certification label was not affixed to the product.