Device 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
Z-0162-2020
Product summary
- Firm
- Xintec Corp
- Event
- Event 83902
- Status
- Terminated
- Classification
- Class III
- Quantity
- 45 lasers
- Official record key
device-enforcement:Z-0162-2020
Official wording
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.
Code information: Lot # 21144, Use by 08/10/2021
Distribution pattern: PA and VA
Derived failure modes
-
Unknown
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.