Recall Z-1918-2015— New Star Lasers, Inc.
Class II · Terminated
Class II FDA medical device recall by New Star Lasers, Inc., initiated 2015-05-13, terminated 2016-10-28. It names one FDA 510(k) clearance: K142286. 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.. 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
- New Star Lasers, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-13
- Terminated
- 2016-10-28
- Firm location
- Roseville, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.