GreenLight HPS — Class II medical device recall Z-0700-2013
Terminated recall by AMS Innovative Center - San Jose, reported 2013-01-30. During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to th
| Recall number | Z-0700-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMS Innovative Center - San Jose, San Jose, CA, United States |
| Recall initiated | 2012-12-11 |
| Classified | 2013-01-22 |
| Reported by FDA | 2013-01-30 |
| Terminated | 2014-02-13 |
| Quantity | 389 devices |
| 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 and 364 more |
| Model numbers | 0010-0070, 0010-0077, 0010-0210 |
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 for recall
During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0700-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.