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Terminated

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

FDA Recall Z-0162-2020 · Posted 2019-10-18

Recalling FirmXintec Corp
Recall StatusTerminated
Product CodeGEX
Date Initiated2017-10-29
Date Terminated2021-04-28
Product Quantity45 lasers

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.

Firm 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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

PA and VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992866OPTILITE IX LASER SURGERY ACCESSORIESConvergent Laser Technologies · 1999-11-18

Official Source

View FDA Recall →

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

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