Z-0834-2011

GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System...

Name: Z-0834-2011 GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System...
Creator: AMS Innovative Center - San Jose
Published: 2010-07-14
License: https://open.fda.gov/license/

American Medical Systems Innovation Center - Silicon Valley / initiated 2010-07-14 / Terminated / root cause: labeling and UDI

FDA source

AMS Innovative Center - San Jose began a recall of 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... on 2010-07-14. The reason FDA records is "Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0834-2011
Status: Terminated
Initiated: 2010-07-14
Posted: 2010-12-29
Terminated: 2011-01-03
Recalling firm: American Medical Systems Innovation Center - Silicon Valley
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.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Product not intended for release was distributed, which may result in old components, not built to specifications, or undergo final testing
Root cause tag: labeling and UDI
FDA 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 in commerce: 77 units
Distribution: Worldwide Distribution, USA including TX, OH, MO, FL, MA, CA, IL, NY, VA, and the country of Australia.
Product codes and lots: Part number 0010-2400, lot numbers 01P, 024P, and 025A

Product code GEX

K100746Class IIFiber OneAmerican Medical Systems / cleared 2010-06-11

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)