Recall Z-1309-2008
National Biological Corp · initiated February 19, 2008
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.
Codes / lots: Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
Reason for recall
Software allows operator to override "low line voltage" error warning and store light intensity value.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-1309-2008
- Initiated
- February 19, 2008
- Posted by FDA
- August 28, 2008
- Terminated
- September 20, 2011
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Quantity
- 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.
- Recalling firm
- National Biological Corp, Beachwood, OH