Events

Rappel de Device Recall Lipoplasty

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 Solta Medical 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
    77655
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3047-2017
  • Date de mise en oeuvre de l'événement
    2017-06-01
  • 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=157186
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
  • Cause
    Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. this only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
  • Action
    Consignees were telephoned on June 1, 2017, as initial recall notification. At that time, all consignees agreed to discontinue use of the affected product until it was returned or repaired. An Urgent Medical Device Recall letter dated June 14, 2017, requested that consignees that have not been contacted regarding this recall and have a device repaired between the dates of 09/08/2016 and 05/23/2017 contact Solta Medical immediately at 877-782-2286. Any questions regarding the recall can be directed to Solta Medical Product Support Team at 877-782-2286 or 510-259-5299, option 2.

Device

Device Recall Lipoplasty
  • Modèle / numéro de série
    Reference No. 110-0021; Shipping P/N P007021-03; Device P/N P006982-03; Serial No. VAS10-0134, VAS13-0440, VAS12-0203, 000TWY.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Distribution
    US Distribution to the states of : AL, CA, CO, FL, NY, PA, & TX.
  • Description du dispositif
    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA || The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
  • Manufacturer
    Solta Medical Inc

Manufacturer

Solta Medical Inc
  • Adresse du fabricant
    Solta Medical Inc, 11720 N Creek Pkwy N Ste 100, Bothell WA 98011-8244
  • Société-mère du fabricant (2017)
    Bausch Health Cos., Inc.
  • Source
    USFDA