FDA recall Z-1392-2022

Product

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

Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.

Key facts

Status

Ongoing

Initiation date

2022-05-31

Report date

2022-07-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1392-2022