—#194455

Product

GreenLight HPSEA Laser Fibers, UPN 0010-2092

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K062719
Affected lot / code info: UDI-DI (GTIN): 00878953005522 Lot: 27770466

Why it was recalled

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.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

On May 31, 2022, the firm distributed Urgent Medical Device Product Removal letters to affected customers. Customers were instructed to immediately segregate and return the product to Boston Scientific.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

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

Timeline

Recall initiated: 2022-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194455. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.