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U.S. Department of Health and Human Services

Class 3 Device Recall HOUVA III Phototherapy System with DermaSense Technology

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 Class 3 Recall
HOUVA III Phototherapy System with DermaSense Technology
see related information
Date Posted August 28, 2008
Recall Status1 Open
Recall Number Z-1309-2008
Recall Event ID 46834
Premarket Notification
510(K) Number
K041212 
Product Classification Light, Ultraviolet, Dermatological - Product Code FTC
Product 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.
Code Information Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
Recalling Firm/
Manufacturer
National Biological Corp
23700 Mercantile Rd
Beachwood, Ohio 44122-5900
Manufacturer Reason
for Recall
Software allows operator to override "low line voltage" error warning and store light intensity value.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 48 Units
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTC and Original Applicant = NATIONAL BIOLOGICAL CORP.
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