Events

Rappel de Dermalight 80, UVB083

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 National Biological Corp.

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
    65494
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1779-2013
  • Date de mise en oeuvre de l'événement
    2013-04-08
  • Date de publication de l'événement
    2013-07-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119281
  • 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, non heating - Product Code FTC
  • Cause
    The incorrect manual may have been packaged with this product. uvb-083 devices may have included the manual for a uva-080 device.
  • Action
    The firm, National Biological, sent an "VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated May 10, 2013 to its consignees/customers by UPS or other delivery service with a signature required. The letter described the product, problem and actions to be taken. Consignees/customers who do not respond to the letter will be contacted via telephone. The customers were instructed to check within your household to determine if you have any of the listed product; immediately destroy the incorrect User Manual, it is not necessary to return the product; record the Customer Name and or the Dermalight-80 serial number and complete and return the enclosed Verification Form, even if you do not have any User Manuals to destroy. Please contact your National Biological Corporation sales representative if you have any questions regarding this recall, any of our products, or would like assistance with the recall call 216-831-0600 or 800-338-5045 email: infor@PhototherapyExperts.com.

Device

Dermalight 80, UVB083
  • Modèle / numéro de série
    The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US distribution including the states of: AL, CA, MN, and NC.
  • Description du dispositif
    Dermalight 80 Model Number UVB-083, one unit per box. || The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
  • Manufacturer
    National Biological Corp

Manufacturer

National Biological Corp
  • Adresse du fabricant
    National Biological Corp, 23700 Mercantile Rd, Beachwood OH 44122-5900
  • Société-mère du fabricant (2017)
    National Biological Corporation
  • Source
    USFDA