Company: New Star Lasers, Inc.
Date of Enforcement Report: June 27, 2015
Class II
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.
Recall Number:
Z-1918-2015
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.
RECALLING FIRM/MANUFACTURER:
New Star Lasers, Inc.
VOLUME OF PRODUCT IN COMMERCE:
52 units
DISTRIBUTION:
Worldwide Distribution — US, including the states of CA, IL, AZ, FL, OH, MA, MI, and AL; and the country of the Netherlands.
