Recall Z-1309-2008 ยท FTC Light, Ultraviolet, Dermatological
National Biological Corp
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.
| Date | Aug 28, 2008 (initiated Feb 19, 2008) |
| Status | Terminated |
| Reason | Software allows operator to override "low line voltage" error warning and store light intensity value. |
| 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 u |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041212 | HOUVA 3 PHOTOTHERAPY SYSTEM National Biological Corp., Jun 9, 2004 |