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U.S. Department of Health and Human Services

Class 3 Device Recall GreenLight HPSEA Laser Fibers

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 Class 3 Device Recall GreenLight HPSEA Laser Fiberssee related information
Date Initiated by FirmMay 31, 2022
Create DateJuly 15, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1392-2022
Recall Event ID 90458
510(K)NumberK062719 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductGreenLight 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 ContactRebecca 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
ActionOn 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 Commerce57
DistributionDomestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = GEX
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