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U.S. Department of Health and Human Services

Class 2 Device Recall iCat Classic, 3D Dental Imaging System

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 Class 2 Recall
iCat Classic, 3D Dental Imaging System
see related information
Date Posted December 17, 2009
Recall Status1 Terminated on September 30, 2010
Recall Number Z-0543-2010
Recall Event ID 53771
Premarket Notification
510(K) Number
K051980 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.
Code Information Serial Numbers: ICU070427, ICU070428, ICU070429, ICU070430, ICU070432, ICU070433, ICU070434, ICU070435, ICU070436, ICU070437, ICU070438, ICU070439, ICU070440, ICU070441, ICU070442, ICU070443, ICU070445, ICU070446, ICU070447, ICU070448, ICU070449, ICU070451, ICU070452, ICU070453, ICU070454, ICU070455, ICU070456, ICU070457, ICU070458, ICU070459, ICU070460, ICU070461, ICU070462, ICU070463, ICU070464, ICU070465, ICU070466, ICU070467, ICU070468, ICU070469, ICU070470, ICU070471, ICU070472, ICU070473, ICU070474, ICU070475, ICU070476, ICU070477, ICU070478, ICU070479, ICU070480, ICU070481, ICU070482, ICU070483, ICU070484, ICU070485, ICU070486, ICU070487, ICU070488, ICU070489, ICU070490, ICU070491, ICU070492, ICU070493, ICU070494, ICU070495, ICU070497, ICU070498, ICU070499, ICU070500, ICU070501, ICU070502, ICU070503, ICU070505, ICU070506, ICU070507, ICU070508, ICU070509, ICU070510, ICU070512, ICU070513, ICU070514, ICU070515, ICU070516, ICU070517, ICU070518, ICU070519, ICU070520, ICU070521, ICU070522, ICU070523, ICU070524, ICU070525, ICU070527, ICU070528, ICU070529, ICU070530, ICU070531 and ICU070532.
Recalling Firm/
Manufacturer
Imaging Sciences International, LLC
1910 North Penn Rd
Hatfield, Pennsylvania 19440-1960
Consumer Instructions No consumer action necessary
For Additional Information Contact Laura Boyd
215-997-5665
Manufacturer Reason
for Recall
overhead carriage drops quickly
FDA Determined
Cause 2
DESIGN: Device Design
Action Imaging Sciences International issued an "Urgent Medical Device Recall" notification dated October 30, 2009 to all customers informing them of the problem and that a field service representative would schedule a visit to install an upgrade kit. For further information, contact Imaging Sciences International at 1-800-205-3570, option 5.
Quantity in Commerce 98 units
Distribution Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan.
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.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = IMAGING SCIENCES INTL., INC.
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