HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic prod
FDA device recall Z-1309-2008 · posted 2008-08-28 · Terminated
Recall details
- Recalling firm
- National Biological Corp
- Reason for recall
- Software allows operator to override "low line voltage" error warning and store light intensity value.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FTC
- Quantity affected
- 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.
- Date initiated
- 2008-02-19
- Date posted
- 2008-08-28
- Date terminated
- 2011-09-20
- Location
- Beachwood, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOUVA 3 PHOTOTHERAPY SYSTEM (K041212) | National Biological Corp. | 2004-06-09 |