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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 Device Recall iCAT Classic 3D Dental Imaging System see related information
Date Initiated by Firm March 19, 2008
Date Posted September 01, 2008
Recall Status1 Terminated 3 on May 05, 2009
Recall Number Z-1645-2008
Recall Event ID 47535
510(K)Number K051980  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product i-CAT Classic 3D Dental Imaging System
Code Information Part number 9140-0000-0000
Recalling Firm/
Manufacturer		 Imaging Sciences Intl Inc
1910 N Penn Rd
Hatfield PA 19440-1960
For Additional Information Contact Colleen Boswell
714-516-7484
Manufacturer Reason
for Recall		 incorrect scatter labeling
FDA Determined
Cause 2		 Error in labeling
Action Firm issued Urgent Medical Device Recall letters dated 3/19/08 to their customers. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. If you have questions or have not received this letter, contact Francine McCoonse at 215-997-5666 ext 1340.
Quantity in Commerce 1203 units
Distribution The products were shipped to distributors and dental offices nationwide. The products were also shipped to Canada, Austria, Belgium, Czech Republic, England, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Lavenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Australia, New Zealand, Chile, Israel, South Korea, UAE, India, Argentina, Brazil, China, Columbia, Hong Kong, Jamaica, Korea, Lebanon, Malaysia, Morocco, Russia, Scotland, Taiwan, Thailand, and Singapore.
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.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = IMAGING SCIENCES INTL., INC.
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