Beijing Syntech Laser Co., Ltd recalls Beijing Syntech Laser Diode Laser surgical lasers
- Recall date
- July 3, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1488-2018
- FDA classification
- Class II
- Brand / firm
- Beijing Syntech Laser Co., Ltd
- Sold / distributed
- US Distribution
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".
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Beijing Syntech Laser Diode Laser surgical lasers
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