Device Recall Titan XL

  • Model / Serial
    All products manufactured before October 1, 2009 with gold plated end blocks.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OK, OR, PA, OH, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cypress, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Lle de la Reunion, Mexico, New Zealand, Phillipines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, UAE, and Ukraine.
  • Product Description
    Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA || Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cutera Inc, 3240 Bayshore Blvd, Brisbane CA 94005
  • Manufacturer Parent Company (2017)
  • Source
    USFDA