Events

Rappel de Device Recall StoneLight 30 Laser System (NS3000)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par New Star Lasers, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71346
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1918-2015
  • Date de mise en oeuvre de l'événement
    2015-05-13
  • Date de publication de l'événement
    2015-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137356
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Powered laser surgical instrument - Product Code GEX
  • Cause
    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.
  • 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.

Device

Device Recall StoneLight 30 Laser System (NS3000)
  • Modèle / numéro de série
    Part Number: 0010-9400. Serial numbers: AMVM01, AMVM06, AMVM07, AMVG01, AMVP05, AMVP07, AMVP13, AMVS05, AMVK02, AMVS03, AMVS07, AMVE01, AMVS06, AMVP03, AMVS08. AMVS09, AMVS10, AMVS11, AMVS12, AMVM04, AMVM08, AMVM09, AMVM05, AMVS02, AMVK05, AMVP10, AMVS11, AMVP12, AMVP14, AMVP15, AMVP16, AMVP17, AMVP18. AMVS01, AMVK01, AMVK03, AMVK04, AMVK06, AMVK07, AMVK08, AMVK09, AMVK10, AMVM02, AMVM03, AMVM10, AMVP01, AMVP02, AMVP04, AMVP06, AMVP08, AMVP09, AMVS04.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of CA, IL, AZ, FL, OH, MA, MI, and AL; and the country of the Netherlands.
  • Description du dispositif
    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
    New Star Lasers, Inc.

Manufacturer

New Star Lasers, Inc.
  • Adresse du fabricant
    New Star Lasers, Inc., 9085 Foothills Blvd, Roseville CA 95747-7130
  • Société-mère du fabricant (2017)
    New Star Lasers Inc.
  • Source
    USFDA