Z-1392-2022 Class III Ongoing
FDA device recall Z-1392-2022 was initiated by Boston Scientific Corporation on May 31, 2022 and is designated Class III. 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… The recall status is ongoing. Affected quantity: 57.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 27, 2022
- Initiation Date
- May 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57
Product Description
GreenLight HPSEA Laser Fibers, UPN 0010-2092
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.
Distribution Pattern
Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Code Information
UDI-DI (GTIN): 00878953005522 Lot: 27770466
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1392-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026