Events

Recall of Device Recall Titan XL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cutera Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55840
  • Event Risk Class
    Class 2
  • Event Number
    Z-0329-2011
  • Event Initiated Date
    2010-05-08
  • Event Date Posted
    2010-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92015
  • Notes / Alerts
    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.
  • Extra notes in the data
    Lamp, infrared, therapeutic heating - Product Code ILY
  • Reason
    Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.
  • Action
    Cutera sent Certified letters sent to all consignees on May 8, 2010. The letter identified the product, the problem, and the action the consignees should take. Consigness were instructed to immediately stop using the handpiece and complete the attached Recall Tracker Form. A second letter was sent to customers who received a replacement handpiecce but did not return the affected devices. All affected products were to be exchanged for new or reworked devices. For questions contact customer service at (888) 428-8372, ext 5561.

Device

Device Recall Titan XL
  • Model / Serial
    All products manufactured before October 1, 2009 with gold plated end blocks.
  • Product Classification
    Physical Medicine Devices
  • 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
    Cutera Inc

Manufacturer

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