New Star Lasers, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1918-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 13, 2015

Date Posted: July 8, 2015

Recall Number: Z-1918-2015

Event ID: 71346

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.

Status: Terminated

Product Quantity: 52 units

Code Information:

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.

Distribution Pattern:

Worldwide Distribution -- US, including the states of CA, IL, AZ, FL, OH, MA, MI, and AL; and the country of the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated