Date Initiated by Firm | May 31, 2022 |
Create Date | July 15, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1392-2022 |
Recall Event ID |
90458 |
510(K)Number | K062719 |
Product Classification |
Powered laser surgical instrument - Product Code GEX
|
Product | GreenLight HPSEA Laser Fibers, UPN 0010-2092 |
Code Information |
UDI-DI (GTIN): 00878953005522
Lot: 27770466 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 100 Boston Scientific Way Marlborough MA 01752-1234
|
For Additional Information Contact | Rebecca Kinkead Rubio 763-494-1133 |
Manufacturer 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 2 | 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 in Commerce | 57 |
Distribution | Domestic distribution to AR
CA
IL
ME
MI
NC
TX
Foreign distribution to Australia, Canada, and France. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = GEX
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