GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System)
Medical device recall Z-0700-2013. Published in FDA’s Enforcement Report on Jan 30, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 30, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 389 devices, all model numbers. how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
389 devices, all model numbers., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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 XPS50354 XPS50355 XPS50356C1 XPS50357 XPS50358 XPS50359 XPS50360 XPS50361 XPS50362 XPS50363 XPS50364 XPS50367 XPS50368 XPS50369 XPS50371 XPS50372C1 XPS50373 XPS50374 XPS50375 XPS50376 XPS50377 XPS50378 XPS50379 XPS50380 XPS50381 XPS50382 XPS50383 XPS50384 XPS50385 XPS50386 XPS50388 XPS50389 XPS50390 XPS50391 XPS50392 XPS50393 XPS50394 XPS50395 XPS50396 XPS50397 XPS50398 XPS50399 XPS50400 XPS50401 XPS50402 XPS50403 XPS50404 XPS50405 XPS50406 XPS50407 XPS50408 XPS50409 XPS50410 XPS50412 XPS50413 XPS50414 XPS50415 XPS50416 XPS50417 XPS50418 XPS50419 XPS50420 XPS50421 XPS50422 XPS50423 XPS50424 XPS50426C1 XPS50427 XPS50428 XPS50430 XPS50431 XPS50432 XPS50433 XPS50434 XPS50435C1 XPS50436 XPS50437C1 XPS50438 XPS50439 XPS50440 XPS50441 XPS50442 XPS50443 XPS50444 XPS50446 XPS50447 XPS50448 XPS50449 XPS50450 XPS50451 XPS50452 XPS50453 XPS50454 XPS50455 XPS50456 XPS50457 XPS50458 XPS50459 XPS50460 XPS50461 XPS50462 XPS50463 XPS50464 XPS50465 XPS50466 XPS50467 XPS50468 XPS50469 XPS50470 XPS50471 XPS50472 XPS50473 XPS50474 XPS50475 XPS50476 XPS50477C1 XPS50478 XPS50479 XPS50480 XPS50481 XPS50482…
FDA’s list runs to 3,585 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 11, 2012.
- FDA classified it on Jan 22, 2013.
- FDA’s Enforcement Report published it on Jan 30, 2013.
- FDA terminated it on Feb 13, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- AMS Innovative Center - San Jose, of San Jose, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,585 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.