FDA Device recall Z-1918-2015
StoneLight 30 Laser System (NS3000)
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of StoneLight 30 Laser System (NS3000) by New Star Lasers, citing 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 deli….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1918-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-13 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | New Star Lasers |
| Distribution | AL, AZ, CA, FL, IL, MA, MI, OH |
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
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.
Identifiers
| code_info | Part Number: 0010-9400. Serial numbers: AMVM01, AMVM06, AMVM07, AMVG01, AMVP05, AMVP07, AMVP13, AMVS05, AMVK02, AMVS0…Part Number: 0010-9400. Serial numbers: AMVM01, AMVM06, AMVM07, AMVG01, AMVP05, AMVP07, AMVP13, AMVS05, AMVK02, AMVS03, AMVS07, AMVE01, AMVS06, AMVP03, AMVS08. AMVS09, AMVS10, AMVS11, AMVS12, AMVM04, AMVM08, AMVM09, AMVM05, AMVS02, AMVK05, AMVP10, AMVS11, AMVP12, AMVP14, AMVP15, AMVP16, AMVP17, AMVP18. AMVS01, AMVK01, AMVK03, AMVK04, AMVK06, AMVK07, AMVK08, AMVK09, AMVK10, AMVM02, AMVM03, AMVM10, AMVP01, AMVP02, AMVP04, AMVP06, AMVP08, AMVP09, AMVS04. |
|---|
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-1918-2015%22
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