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.
This recall has been terminated (originally issued August 28, 2008).
- Company
- National Biological Corp
- Recall Initiated
- February 19, 2008
- Posted
- August 28, 2008
- Terminated
- September 20, 2011
- Recall Number
- Z-1309-2008
- Quantity
- 48 Units
- Firm Location
- Beachwood, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Software allows operator to override "low line voltage" error warning and store light intensity value.
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.
Lot / Code Info
Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
Root 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.