FDA Device recall Z-0700-2013
GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation…
- FDA Device
- Class II
- terminated
- Published 2013-01-30
On 2013-01-30 the FDA classified a Class II recall of GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation… by Ams Innovative Center San Jose, citing during electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0700-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-11 |
| Published | 2013-01-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ams Innovative Center San Jose |
| Distribution | n/a |
Product
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.
Reason
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Identifiers
| code_info | HPS Part numbers: 0010-0070 to 0010-0077; XPS Part numbers: 0010-0210 Serial numbers: HPS2095R1 HPS3079C2 HPS3080C…HPS Part numbers: 0010-0070 to 0010-0077; XPS Part numbers: 0010-0210 Serial numbers: HPS2095R1 HPS3079C2 HPS3080C1 HPS3089C1 HPS3091C1 HPS3096C1 HPS3099C1 HPS3100C1 HPS3101C1 HPS3102C1 HPS3103 HPS3104C1 HPS3105C1 HPS3107 HPS3108C1 HPS3109C1 HPS3110C2 HPS3112 HPS3113 HPS3114 HPS3115 HPS3116 HPS3117 HPS3118 HPS3119 HPS3120 HPS3121 HPS3122 HPS3123 HPS3124 HPS3125 HPS3126 HPS3127 HPS3128 HPS3129 HPS3130 HPS3131 HPS3132 HPS3134 HPS3136 HPS3137 HPS3139 HPS3142 HPS3143 HPS3144 HPS3145 XPS50084 XPS50241 XPS50301 XPS50302 XPS50312 XPS50313 XPS50314 XPS50315 XPS50316 XPS50317 XPS50318 XPS50319 XPS50320 XPS50321 XPS50322 XPS50323 XPS50324 XPS50325 XPS50326 XPS50327 XPS50328 XPS50329 XPS50330 XPS50331 XPS50332 XPS50333 XPS50334 XPS50335 XPS50336 XPS50337 XPS50338 XPS50339 XPS50340 XPS50341 XPS50342 XPS50343 XPS50344 XPS50345 XPS50346 XPS50347 XPS50348 XPS50349 XPS50350 XPS50351 XPS50352 XPS50353 XPS5035 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0700-2013%22
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