130 results
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90ms
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Sources: EU EUDAMED, US FDA
GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·April 17, 2007
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
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·June 18, 2007
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.
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·February 8, 2010
GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.
FDA Enforcement
Class II
·Terminated·AMS Innovative Center - San Jose·January 30, 2013
ANGLED DELIVERY DEVICE, GREENLIGHT XPS
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·May 31, 2012
ANGLED DELIVERY DEVICE, GREENLIGHT XPS
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·May 2, 2012
ANGLED DELIVERY DEVICE, GREENLIGHT
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·June 5, 2012
ANGLED DELIVERY DEVICE, GREENLIGHT
FDA Adverse Event
Injury
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·May 7, 2012
ANGLED DELIVERY DEVICE, GREENLIGHT
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·June 5, 2012
ANGLED DELIVERY DEVICE, GREENLIGHT
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·May 11, 2012
GREENLIGHT SURGICAL LASER SYSTEM
FDA Adverse Event
Injury
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·May 7, 2012
ANGLED DELIVERY DEVICE, GREENLIGHT XPS
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·April 4, 2012
ANGLED DELIVERY DEVICE, GREENLIGHT XPS
FDA Adverse Event
Injury
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·January 26, 2012
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·January 14, 2013
GREENLIGHT HPS FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·January 15, 2013
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·February 15, 2013
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·January 14, 2013
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·January 15, 2013
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·March 29, 2013
GREELIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·January 15, 2013