OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot
FDA device recall Z-0162-2020 · posted 2019-10-18 · Terminated
Recall details
- Recalling firm
- Xintec Corp
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 45 lasers
- Distribution
- PA and VA
- Date initiated
- 2017-10-29
- Date posted
- 2019-10-18
- Date terminated
- 2021-04-28
- Location
- Alameda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTILITE IX LASER SURGERY ACCESSORIES (K992866) | Convergent Laser Technologies | 1999-11-18 |