Date Initiated by Firm |
October 29, 2017 |
Date Posted |
October 18, 2019 |
Recall Status1 |
Terminated 3 on April 28, 2021 |
Recall Number |
Z-0162-2020 |
Recall Event ID |
83902 |
510(K)Number |
K992866
|
Product Classification |
Powered Laser Surgical Instrument - Product Code GEX
|
Product |
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036 |
Code Information |
Lot # 21144, Use by 08/10/2021 |
Recalling Firm/ Manufacturer |
Xintec Corp 1660 S Loop Rd Alameda CA 94502-7091
|
For Additional Information Contact |
Jennifer Mok 510-832-2130 Ext. 1207
|
Manufacturer Reason for Recall |
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
|
FDA Determined Cause 2 |
Software Manufacturing/Software Deployment |
Action |
On October 29, 2017, the firm contacted consignees via phone. During the phone the following information was provided:
1. Convergent has become aware of an issue affecting one lot of the fibers that have been purchased recently. The affected product is the CGH1080F fibers with lot number 21144. It has been determined that the fibers in that batch were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser with it is plugged in. There have been no reports of adverse reactions related to this issue. Please return the products to Convergent. In return, we will send replacement fibers to you. |
Quantity in Commerce |
45 lasers |
Distribution |
PA and VA |
Total Product Life Cycle |
TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GEX and Original Applicant = CONVERGENT LASER TECHNOLOGIES
|