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New Star Lasers, Inc. recalls StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision,
Recalled July 8, 2015 · FDA recall Z-1918-2015 · New Star Lasers
Hazard
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. · FDA Class II
Units
52 units
Sold at
Worldwide Distribution -- US, including the states of CA, IL, AZ, FL, OH, MA, MI, and AL; and the country of the Netherlands.
Description
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.
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.
Manufacturer(s)
New Star Lasers, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →