Reported May 9, 2018 · Ongoing
Beijing Syntech Laser Trixel C02 Laser surgical lasers
Beijing Syntech Laser Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beijing Syntech Laser Co., Ltd · International Industry Base · Beijing, N/A · N/A
Is this the product you have?
- Beijing Syntech Laser Trixel C02 Laser surgical lasers
- Lot codes and dates
- Model Trixel C02 Laser
- Amount recalled
- 38
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Why it was recalled
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".
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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