FDA Medical Device Recalls (openFDA)
AMS Innovative Center - San Jose: GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
- Recall number
- Z-0834-2011
- Recalling firm
- AMS Innovative Center - San Jose
- Product
- GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
- Status
- Terminated
- Initiated
- 2010-07-14
- Posted
- 2010-12-29
- Terminated
- 2011-01-03
- Reason
- Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
- Root cause
- Labeling mix-ups
- Action
- American Medical Systems sent oral notifications that the product used for patient case evaluations was from the 2 year shelf life study. Products have been returned, as the product was with AMS field personnel. For questions regarding this recall call 847-855-6270.
- Quantity
- 77 units
- Distribution
- Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.
- Lot, serial or model codes
- Part number 0010-2400, lot numbers 01P, 024P, and 025A
- 510(k) numbers
- ["K100746"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 2937094
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28