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Open, Classified

GreenLight HPSEA Laser Fibers, UPN 0010-2092

FDA Recall Z-1392-2022 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2022-05-31
Product Quantity57

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.

Firm Action

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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062719GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESLaserscope · 2006-12-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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