Device Recall Thermage

  • Model / Serial
    M00023,  M00024,  M00029, M00031, M00033R, M00034, M00035,
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    ThermaCool TC 1.0 cm2 Treatment Tip, || Single Patient Use Only
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Thermage, 4058 Point Eden Way, Hayward CA 94545-3721
  • Source
    USFDA