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Boston Scientific Corporation recalls GreenLight HPSEA Laser Fibers, UPN 0010-2092
Recalled July 27, 2022 · FDA recall Z-1392-2022 · Boston Scientific
Hazard
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. · FDA Class III
Units
57
Sold at
Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Description
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.
Product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →