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Class 3 Device Recall HOUVA III Phototherapy System with DermaSense Technology |
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Date Initiated by Firm |
February 19, 2008 |
Date Posted |
August 28, 2008 |
Recall Status1 |
Terminated 3 on September 20, 2011 |
Recall Number |
Z-1309-2008 |
Recall Event ID |
46834 |
510(K)Number |
K041212
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Product Classification |
Dermatological Ultraviolet Light - Product Code FTC
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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 OH 44122-5900
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For Additional Information Contact |
216-831-0600
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Manufacturer Reason for Recall |
Software allows operator to override "low line voltage" error warning and store light intensity value.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FTC and Original Applicant = NATIONAL BIOLOGICAL CORP.
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