Z-1309-2008

HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A...

Name: Z-1309-2008 HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A...
Creator: National Biological Corp
Published: 2008-02-19
License: https://open.fda.gov/license/

National Biological Corp. / initiated 2008-02-19 / Terminated / root cause: software

FDA source

National Biological Corp began a recall of HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who... on 2008-02-19. The reason FDA records is "Software allows operator to override "low line voltage" error warning and store light intensity value". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1309-2008
Status: Terminated
Initiated: 2008-02-19
Posted: 2008-08-28
Terminated: 2011-09-20
Recalling firm: National Biological Corp.
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.
Product code: FTC Light, Ultraviolet, Dermatological
Reason for recall: Software allows operator to override "low line voltage" error warning and store light intensity value.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122

Product code FTC

K041212Class IIHouva 3 Phototherapy SystemNational Biological Corp. / cleared 2004-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)