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Class 2 Device Recall iCAT 1719 Cone Beam 3D Dental Imaging System |
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Date Initiated by Firm |
March 19, 2008 |
Date Posted |
September 01, 2008 |
Recall Status1 |
Terminated 3 on May 05, 2009 |
Recall Number |
Z-1646-2008 |
Recall Event ID |
47535 |
510(K)Number |
K061284
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Product Classification |
System, X-Ray, Extraoral Source, Digital - Product Code MUH
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Product |
i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam |
Code Information |
Part number 1-10-1-0. The KaVo part number is K1-10-3-0 |
Recalling Firm/ Manufacturer |
Imaging Sciences Intl Inc 1910 N Penn Rd Hatfield PA 19440-1960
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For Additional Information Contact |
Colleen Boswell 714-516-7484
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Manufacturer Reason for Recall |
Incorrect scatter information in the manual.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MUH and Original Applicant = IMAGING SCIENCES INTL., INC.
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