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U.S. Department of Health and Human Services

Class 2 Device Recall Image Consultant (IC) Software

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  Class 2 Device Recall Image Consultant (IC) Software see related information
Date Initiated by Firm February 05, 2010
Date Posted March 22, 2010
Recall Status1 Terminated 3 on June 14, 2010
Recall Number Z-1176-2010
Recall Event ID 54633
Product Classification Device, storage, images, ophthalmic - Product Code NFF
Product Image Consultant (IC) Software
Code Information product is not coded
Recalling Firm/
R.O. Gulden & Co., Inc.
225 Cadwalader Ave
Elkins Park PA 19027-2020
For Additional Information Contact Thomas Cockly
Manufacturer Reason
for Recall
Software not validated; inaccurate results may occur.
FDA Determined
Cause 2
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.
Quantity in Commerce 20
Distribution The product was shipped to eye doctors/clinics in AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, and WA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.