FDA Device

Image Consultant (IC) Software

Hazard

Software not validated; inaccurate results may occur.

What You Should Do

Remedy

On 2/5/10, the recalling firm issued letters via certified mail to its consignees informing them of the problem and to cease use of the software for diagnosis.

Products

Image Consultant (IC) Software
Brand
R.O. Gulden & Co., Inc.
UPC
product is not coded

Units Affected

20