Z-1392-2022Class III

GreenLight HPSEA Laser Fibers, UPN 0010-2092

Name: Z-1392-2022 GreenLight HPSEA Laser Fibers, UPN 0010-2092
Creator: Boston Scientific Corporation
Published: 2022-05-31
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-05-31 / Open, Classified / root cause: software

FDA source

Boston Scientific Corporation began a recall of GreenLight HPSEA Laser Fibers, UPN 0010-2092 on 2022-05-31. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1392-2022
Classification: Class III
Status: Open, Classified
Initiated: 2022-05-31
Posted: 2022-07-15
Recalling firm: Boston Scientific Corporation
Product: GreenLight HPSEA Laser Fibers, UPN 0010-2092
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: software
FDA 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 in commerce: 57
Distribution: Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Product codes and lots: UDI-DI (GTIN): 00878953005522 Lot: 27770466

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1392-2022	Class III	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-15

Product code GEX

K062719Class IIGreenlight Hps Series Surgical Laser System & AccessoriesLaserscope / cleared 2006-12-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)