Device Recall Thermage

  • Modèle / numéro de série
    M00023,  M00024,  M00029, M00031, M00033R, M00034, M00035,
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed nationwide. A total of 54 consignees received the product. The recall was appropriately extended to the user level; i.e., the wholesalers/distributors, hospitals and medical supply distributors, and physicians who received the recalled product. There is no known U. S. Government or Canadian distribution.
  • Description du dispositif
    ThermaCool TC 1.0 cm2 Treatment Tip, || Single Patient Use Only
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Thermage, 4058 Point Eden Way, Hayward CA 94545-3721
  • Source
    USFDA