New Star Lasers, Inc. recalls StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, e…

Recall date

May 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1918-2015

FDA classification

Class II

Brand / firm

New Star Lasers, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.