FDA Medical Device Recalls (openFDA)
Beijing Syntech Laser Co., Ltd: Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
- Recall number
- Z-1490-2018
- Recalling firm
- Beijing Syntech Laser Co., Ltd
- Product
- Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
- Status
- Open, Classified
- Initiated
- 2017-07-03
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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".
- Root cause
- Nonconforming Material/Component
- 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
- Quantity
- 3
- Distribution
- US Distribution
- Lot, serial or model codes
- Model Trixel 11 C02 Laser
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3007535734
- Firm city
- Beijing
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28