GreenLight HPSEA Laser Fibers, UPN 0010-2092
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 57 GreenLight HPSEA Laser Fibers (Lot 27770466) that were distributed domestically to Arkansas, California, Illinois, Maine, Michigan, North Carolina, and Texas, as well as internationally to Australia, Canada, and France. Users of the affected laser fibers experienced a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, which required replacement of both the laser fiber and fiber card during procedures.
The error message and resulting need to replace equipment during use can cause procedures to be prolonged. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 57 Lot/code info: UDI-DI (GTIN): 00878953005522 Lot: 27770466
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.