FDA Recall: Discrepancy in Energy Delivered vs Value Displayed

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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