Recall Z-1392-2022 ยท GEX Powered Laser Surgical Instrument
Boston Scientific Corporation
GreenLight HPSEA Laser Fibers, UPN 0010-2092
| Date | May 31, 2022 |
| Status | Open, Classified |
| Reason | 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 | Software Manufacturing/Software Deployment |
| 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. |
| Quantity | 57 |
| Distribution | Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES Laserscope, Dec 1, 2006 |