FDA-Device2022-07-27Class III
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Boston Scientific Corporation
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.
Sold states
Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Affected count
57
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1392-2022Don't want to check this manually?
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