Recall Z-0162-2020 ยท GEX Powered Laser Surgical Instrument
Xintec Corp
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
| Date | Oct 18, 2019 (initiated Oct 29, 2017) |
| Status | Terminated |
| Reason | 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 | 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 pr |
| Quantity | 45 lasers |
| Distribution | PA and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992866 | OPTILITE IX LASER SURGERY ACCESSORIES Convergent Laser Technologies, Nov 18, 1999 |