Z-1229-2011

AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS...

Name: Z-1229-2011 AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS...
Creator: AMS Innovative Center - San Jose
Published: 2010-02-08
License: https://open.fda.gov/license/

American Medical Systems Innovation Center - Silicon Valley / initiated 2010-02-08 / Terminated

FDA source

AMS Innovative Center - San Jose began a recall of AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS Solutions, San Jose, CA The GreenLight Surgical... on 2010-02-08. The reason FDA records is "A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1229-2011
Status: Terminated
Initiated: 2010-02-08
Posted: 2011-02-14
Terminated: 2011-02-14
Recalling firm: American Medical Systems Innovation Center - Silicon Valley
Product: AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS Solutions, San Jose, CA The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.
FDA root cause: Other
Action: AMS Innovative Center - San Jose issued Important Product Update Information letters via express mail on February 8, 2010, and September 15, 2010 to all its direct consignees. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to attach the Fiber Guard to their GreenLight PV Laser System, and to complete the Response Form in the enclosed, self-addressed, postage paid envelope to AMS. For any questions regarding this recall call the Customer Care Department at 1-800-356-7600 or send an e-mail to [email protected].
Quantity in commerce: ~242,000 units
Distribution: Worldwide Distribution including US
Product codes and lots: All units of the model.

Product code GEX

K010284Class IILyra G Series Surgical Laser System (Sl Series Q-Switched Nd:yag Configuration)Laserscope / cleared 2001-05-01

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)