Z-1392-2022 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- May 31, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57
Product Description
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Reason for Recall
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.
Distribution Pattern
Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Code Information
UDI-DI (GTIN): 00878953005522 Lot: 27770466