Recall Z-1918-2015 ยท GEX Powered Laser Surgical Instrument
New Star Lasers, Inc.
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.
| Date | Jun 27, 2015 (initiated May 13, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design (manufacturing process) |
| Action | Medical Device Correction letters were sent to all affected consignees by Federal Express on May 13, 2015. The letter identified the affected product as well as the issue and risk involved. The software will be upgraded to address the issue; and, the firm will contact customers to coordinate installation of the upgraded software. Customers may continue to use their system safely by taking the precautions provided in the letter. Customers are to complete the attached response form. Questions should be directed to Nina Davis at 916-677-1909. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142286 | NS3000 Holmium Laser System New Star Lasers, Inc., Oct 31, 2014 |