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New Star Lasers Recalls
4 recalls on record · July 8, 2015 to October 12, 2016 · Medical Devices
Recalls by year
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 12, 2016Medical DevicesFDA
New Star Lasers, Inc. recalls ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemos
Hazard: FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
October 12, 2016Medical DevicesFDA
New Star Lasers, Inc. recalls VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of
Hazard: FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
October 12, 2016Medical DevicesFDA
New Star Lasers, Inc. recalls CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision,
Hazard: FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
July 8, 2015Medical DevicesFDA
New Star Lasers, Inc. recalls StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision,
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.