BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0329-2011 · Initiated May 8, 2010

    Recall

    Recall Number
    Z-0329-2011
    Event Number
    55840
    Firm
    Cutera Inc
    FEI Number
    3002900199
    Product Code
    ILY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 8, 2010
    Posted
    November 9, 2010
    Terminated
    December 28, 2010
    Address
    3240 Bayshore Blvd, Brisbane, CA, 94005

    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.

    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.

    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.

    Quantity

    1,344 units