Events

Recall of Device Recall HOUVA III Phototherapy System with DermaSense Technology

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

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
    46834
  • Event Risk Class
    Class 3
  • Event Number
    Z-1309-2008
  • Event Initiated Date
    2008-02-19
  • Event Date Posted
    2008-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68319
  • 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
    Dermatological Ultraviolet Light - Product Code FTC
  • Reason
    Software allows operator to override "low line voltage" error warning and store light intensity value.
  • Action
    National Biological sent an "Important safety reminders for your Houva DermaSense phototherapy device" letters, dated 2/11/08 to users. It states that the user should collect a "Profile" of the light energy and record it on a daily/weekly flow chart. The chart should be in plain view so each operator can clearly determine the units output. If an error message appears in the display panel, treatment should not be continued unless the phototherapy booth operator was able to identify and correct the cause of the error. Make sure both breakers are in the "ON" position before starting up the unit each morning and before giving treatment.

Device

Device Recall HOUVA III Phototherapy System with DermaSense Technology
  • Model / Serial
    Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- USA including states of: CA, DE, FL, GA, ID, IL, IN, MA, MI, MN, NC, NH, NY, OH, OR, PA, TX, VA, WA and WI, and country of Canada.
  • Product Description
    HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. || A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.
  • Manufacturer
    National Biological Corp

Manufacturer

National Biological Corp
  • Manufacturer Address
    National Biological Corp, 23700 Mercantile Rd, Beachwood OH 44122-5900
  • Manufacturer Parent Company (2017)
    National Biological Corporation
  • Source
    USFDA