HOUVA III Phototherapy System with DermaSense Technology… recallZ-1309-2008 · National Biological Corp · initiated Feb 19, 2008
Terminated All recalls posted in August 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from National Biological Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software allows operator to override "low line voltage" error warning and store light intensity value.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1309-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 19, 2008
- Posted by the FDA
- Aug 28, 2008
- Recalling firm
- National Biological Corp
- Quantity
- 48 Units
- Product code
- FTC
- FDA submissions
- K041212
- 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.
Code information (models, lots, serial numbers)
Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
Other devices under the same FDA submission
1 device cleared under K041212 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- National Biological Corporation UHU-318National Biological Corporation · Light, Ultraviolet, Dermatological1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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