Events

Rappel de Device Recall Titan XL

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Cutera Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    55840
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0329-2011
  • Date de mise en oeuvre de l'événement
    2010-05-08
  • Date de publication de l'événement
    2010-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92015
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Lamp, infrared, therapeutic heating - Product Code ILY
  • Cause
    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
  • Modèle / numéro de série
    All products manufactured before October 1, 2009 with gold plated end blocks.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Cutera Inc, 3240 Bayshore Blvd, Brisbane CA 94005
  • Société-mère du fabricant (2017)
    Cutera Inc.
  • Source
    USFDA