Reported Jan 30, 2013 · Terminated
GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions…
AMS Innovative Center - San Jose
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AMS Innovative Center - San Jose · 3070 Orchard Dr · San Jose, CA · 95134-2011
Is this the product you have?
- 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.
- Lot codes and dates
- HPS Part numbers0010-0070 to 0010-0077
- XPS Part numbers0010-0210
- Serial numbers
389 of 389 codes
HPS2095R1HPS3079C2HPS3080C1HPS3089C1HPS3091C1HPS3096C1HPS3099C1HPS3100C1HPS3101C1HPS3102C1HPS3103HPS3104C1HPS3105C1HPS3107HPS3108C1HPS3109C1HPS3110C2HPS3112HPS3113HPS3114HPS3115HPS3116HPS3117HPS3118HPS3119HPS3120HPS3121HPS3122HPS3123HPS3124HPS3125HPS3126HPS3127HPS3128HPS3129HPS3130HPS3131HPS3132HPS3134HPS3136HPS3137HPS3139HPS3142HPS3143HPS3144HPS3145XPS50084XPS50241XPS50301XPS50302XPS50312XPS50313XPS50314XPS50315XPS50316XPS50317XPS50318XPS50319XPS50320XPS50321
- Amount recalled
- 389 devices, all model numbers.
Why it was recalled
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
This product could cause temporary or reversible health problems — stop using it.
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