Recall Z-1392-2022
Boston Scientific Corporation · initiated May 31, 2022
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Codes / lots: UDI-DI (GTIN): 00878953005522 Lot: 27770466
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.
FDA-determined cause: Software Manufacturing/Software Deployment
Action taken
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.
Details
- Recall number
- Z-1392-2022
- Initiated
- May 31, 2022
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 57
- Distribution
- Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA