StoneLight 30 Laser System — Class II medical device recall Z-1918-2015
Terminated recall by New Star Lasers, Inc., reported 2015-07-08, distributed in AL, AZ, CA, FL, IL, MA, MI, OH. During internal testing a situation was discovered where when changing the settings, a new setting could not b
| Recall number | Z-1918-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | New Star Lasers, Inc., Roseville, CA, United States |
| Recall initiated | 2015-05-13 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2016-10-28 |
| Distributed | AL, AZ, CA, FL, IL, MA, MI, OH |
| Countries outside the US | NL |
| Quantity | 52 units |
| Serial numbers | AMVE01, AMVG01, AMVK01, AMVK02, AMVK03, AMVK04, AMVK05, AMVK06, AMVK07, AMVK08, AMVK09, AMVK10, AMVM01, AMVM02, AMVM03, AMVM04, AMVM05, AMVM06, AMVM07, AMVM08, AMVM09, AMVM10, AMVP01, AMVP02, AMVP03 and 26 more |
| Model numbers | 0010-9400 |
Product
StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.
Reason for recall
During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lower) from the value displayed on the Graphical User Interface display.
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-1918-2015. 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.