Z-0131-2008

American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber...

Name: Z-0131-2008 American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber...
Creator: AMS Innovative Center - San Jose
Published: 2007-06-18
License: https://open.fda.gov/license/

American Medical Systems Innovation Center - Silicon Valley / initiated 2007-06-18 / Terminated / root cause: manufacturing process

FDA source

AMS Innovative Center - San Jose began a recall of American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic... on 2007-06-18. The reason FDA records is "Control knob break: The knob used to finely control the direction of the laser energy may break". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0131-2008
Status: Terminated
Initiated: 2007-06-18
Posted: 2008-02-26
Terminated: 2010-03-23
Recalling firm: American Medical Systems Innovation Center - Silicon Valley
Product: American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Control knob break: The knob used to finely control the direction of the laser energy may break.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: American Medical Systems, Inc. (AMS) issued Important: Medical Device Recall AMS Greenlight ADDStat Fibers notification letters to customers who have purchased the product on June 28, 2007. The customer letter requests recipients that the product use be discontinued, and the fibers be returned. The firm will send replacements.
Quantity in commerce: 611 units
Distribution: Worldwide Distribution - USA and Singapore.
Product codes and lots: Part Number: 0010-2090B, Lot Numbers 705 N and 706 E

Product code GEX

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)