Image Consultant (IC) Software
FDA Recall Z-1176-2010 · Posted 2010-03-22
Recalling FirmR.O. Gulden & Co., Inc.
Recall StatusTerminated
Product CodeNFF
Date Initiated2010-02-05
Date Terminated2010-06-14
Product Quantity20
Reason for Recall
Software not validated; inaccurate results may occur.
Firm Action
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.
Root Cause
Other
Distribution Pattern
The product was shipped to eye doctors/clinics in AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.