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Open, Classified

Beijing Syntech Laser UL Station surgical lasers

FDA Recall Z-1495-2018 · Posted None

Recalling FirmBeijing Syntech Laser Co., Ltd
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2017-07-03
Product Quantity199

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".

Firm Action

Beijing 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

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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