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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 Recall
Image Consultant (IC) Software
see related information
Date Posted March 22, 2010
Recall Status1 Terminated 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/
Manufacturer
R.O. Gulden & Co., Inc.
225 Cadwalader Ave
Elkins Park, Pennsylvania 19027-2020
For Additional Information Contact Thomas Cockly
215-884-8105
Manufacturer Reason
for Recall
Software not validated; inaccurate results may occur.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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