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U.S. Department of Health and Human Services

Class 2 Device Recall Laser Handpiece

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 Class 2 Device Recall Laser Handpiecesee related information
Date Initiated by FirmJuly 03, 2017
Create DateMay 02, 2018
Recall Status1 Open3, Classified
Recall NumberZ-1488-2018
Recall Event ID 79697
Product Classification Powered laser surgical instrument - Product Code GEX
ProductBeijing Syntech Laser Diode Laser surgical lasers
Code Information Model Diode Laser
Recalling Firm/
Manufacturer		 Beijing Syntech Laser Co., Ltd
International Industry Base
West Area F/4; No. 8 Liye Road; Changping
Beijing China
For Additional Information Contact
360-325-7028
Manufacturer 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".
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBeijing Syntech Laser measures to be taken: 1. Beijing Syntech Laser Co. Ltd. has sent notifications to all relevant dealers, distributors, and purchasers, 2. Beijing Syntech Laser Co. Ltd. will send certification labels and instructions to apply the label to the product to all relevant dealers, distributors, and purchasers, 3. The corrections will be conducted at no cost to the purchaser, and 4.The corrective action will be completed by August 1st, 2018. CDRH approves the CAP subject to the following condition: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22, if it hasnt been already. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions please call (360) 325-7028
Quantity in Commerce13
DistributionUS Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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