Recall Z-1490-2018 ยท GEX Powered Laser Surgical Instrument
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
| Date | Jul 3, 2017 |
| Status | Open, Classified |
| 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 da |
| Quantity | 3 |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.