Device product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Z-1392-2022
Product summary
- Event
- Event 90458
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 57
- Official record key
device-enforcement:Z-1392-2022
Official wording
Reason: Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.
Code information: UDI-DI (GTIN): 00878953005522 Lot: 27770466
Distribution pattern: Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Derived failure modes
-
Unknown
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.