notyard
09-04-2008, 09:54 AM
FDA class III recall:
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, Recall # Z-1309-2008
CODE
Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
RECALLING FIRM/MANUFACTURER
National Biological Corp., Beachwood, OH, by letters dated February 11, 2008. Firm initiated recall is ongoing.
REASON
Software allows operator to override “low line voltage” error warning and store light intensity value.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
Nationwide and Canada
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, Recall # Z-1309-2008
CODE
Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
RECALLING FIRM/MANUFACTURER
National Biological Corp., Beachwood, OH, by letters dated February 11, 2008. Firm initiated recall is ongoing.
REASON
Software allows operator to override “low line voltage” error warning and store light intensity value.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
Nationwide and Canada