Z-0162-2020Class III

OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with...

Name: Z-0162-2020 OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with...
Creator: Xintec Corp
Published: 2017-10-29
License: https://open.fda.gov/license/

Xintec Corporation / initiated 2017-10-29 / Terminated / root cause: software

FDA source

Xintec Corp began a recall of OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run... on 2017-10-29. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0162-2020
Classification: Class III
Status: Terminated
Initiated: 2017-10-29
Posted: 2019-10-18
Terminated: 2021-04-28
Recalling firm: Xintec Corporation
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
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: Lot # 21144, Use by 08/10/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0162-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0162-2020	Class III	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-18

Product code GEX

K992866Class IIOptilite IX Laser Surgery AccessoriesConvergent Laser Technologies / cleared 1999-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)