Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1491-2018 — Beijing Syntech Laser UL C02 Laser surgical lasers

U.S. FDA — Device Enforcement · China · 2017-07-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1491-2018
Date of alert
2017-07-03
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
Beijing Syntech Laser Co., Ltd
Product category
device
Product type
Devices
Reported risk: 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".
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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