Events

Rappel de truSculpt

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 Cutera, 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
    66674
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0427-2014
  • Date de mise en oeuvre de l'événement
    2013-10-16
  • Date de publication de l'événement
    2013-12-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122929
  • 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
    Massager, vacuum, radio frequency induced heat - Product Code OPT
  • Cause
    Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.
  • Action
    Cutera sent an IMPORTANT SAFETY INFORMATION letter dated October 16, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. It is important that you share this correspondence and the updated Operator Manual andvtreatment guidelines with all staff at your office that use the truSculpt, so they are aware of this new safety information. Please immediately remove and dispose of the current truSculpt Operator Manual and clinical guidelines and replace them with the new and revised truSculpt Operator Manual and clinical guidelines. Customers with questions were instructed to call 415-657-5500 or 415-657-5568.

Device

truSculpt
  • Modèle / numéro de série
    Serial Numbers: TS10140 TS10052 TS10107 TS10161 TS10086 TS10136 TS10083 TS10045 TS10032 TS10075 TS10100 TS10070 TS10129 TS10049 TS10040 TS10055 TS10160 TS10046 TS10117 TS10137 TS10141 TS10080 TS10097 TS10037 TS10131 TS10138 TS10119 TS10088 TS10074 TS10114 TS10145 TS10066 TS10106 TS10155 TS10056 TS10094 TS10139 TS10022 TS10128 TS10112 TS10068 TS10124 TS10078 TS10134 TS10079 TS10002 TS10109 TS10156 TS10135 TS10110 TS10008 TS10115 TS10093 TS10146 TS10050 TS10017 TS10054 TS10029 TS10104 TS10048 TS10090 TS10062 TS10024 TS10158 TS10071 TS10035 TS10059 TS10153 TS10025 TS10087 TS10130 TS10133 TS10101 TS10103 TS10125 TS10018 TS10089 TS10023 TS10147 TS10033 TS10015 TS10014 TS10039 TS10085
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada
  • Description du dispositif
    Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA || The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
  • Manufacturer
    Cutera, Inc.

Manufacturer

Cutera, Inc.
  • Adresse du fabricant
    Cutera, Inc., 3240 Bayshore Blvd, Brisbane CA 94005-1021
  • Société-mère du fabricant (2017)
    Cutera Inc.
  • Source
    USFDA