Events

Rappel de Ablatherm Integrated Imaging device

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 Edap Technomed 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
    78092
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0049-2018
  • Date de mise en oeuvre de l'événement
    2017-08-14
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158643
  • 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
    High intensity ultrasound system for prostate tissue ablation - Product Code PLP
  • Cause
    The us fda has requested the optional energy treatment settings, "medium" and "low" (software protocols 02-medium and 03-low) be removed from all ablatherm integrated imagining devices in the u.S. until supporting clinical data can be submitted and evaluated by fda.
  • Action
    The firm, EDAP TMS, company contacted all affected customers by phone during the week of August 14, 2017 and followed up with an " URGENT FIELD SAFETY NOTICE" letter dated 8/22/2017 delivered by email on 08/29/2016. The letter described the product, problem and actions to be taken. The customers were instructed as follows: do not use the "medium" or "low" energy treatment power settings in the meantime.The devices will be serviced at the consignee to remove Protocols "02-medium" and "03-low". If you have any questions regarding this notification, or experience any issues with your device, please contact EDAP TMS Customer Care Center at (512) 852-9685 or via email at service@edap-usa.com at any time, 24 hours a day, 7 days a week.

Device

Ablatherm Integrated Imaging device
  • Modèle / numéro de série
    Serial Numbers: AB127r, AB206r, AB220r, AB254r, AB200r, AB214r, AB223r, AB266, AB204r, AB217r, AB224r, AB267
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: NY, FL CA, NC, TX and NJ.
  • Description du dispositif
    Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation || Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue
  • Manufacturer
    Edap Technomed Inc.

Manufacturer

Edap Technomed Inc.
  • Adresse du fabricant
    Edap Technomed Inc., 5321 Industrial Oaks Blvd Ste 110, Austin TX 78735-8823
  • Société-mère du fabricant (2017)
    EDAP TMS SA
  • Source
    USFDA