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U.S. Department of Health and Human Services

Class 2 Device Recall iCAT Classic (XRay Tube head and Power Supply)

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  Class 2 Device Recall iCAT Classic (XRay Tube head and Power Supply) see related information
Date Initiated by Firm December 15, 2010
Date Posted August 12, 2011
Recall Status1 Terminated 3 on March 01, 2013
Recall Number Z-3018-2011
Recall Event ID 57583
510(K)Number K051980  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product i-CAT Classic (X-Ray Tube head and Power Supply)

X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, oral surgeon or other physician needs 3D information of high contrast objects.
Code Information Part number 9140-0035 (Tube head) and 9140-1001 (Power Supply)
Recalling Firm/
Manufacturer		 Imaging Sciences International, LLC
1910 North Penn Rd
Hatfield PA 19440-1960
For Additional Information Contact Elizabeth Lazaro
267-954-0365
Manufacturer Reason
for Recall		 Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply
FDA Determined
Cause 2		 Other
Action The firm, Imaging Sciences, sent an "Urgent Medical Device Field Correction" letter dated December 15, 2011 via first class USPS to its customer. The letter noted the product and described the problem and action to be taken. The customer was instructed to complete and return the ACKNOWLEDGEMENT FORM via fax to 215-997-5665 or email: darin.oppenheimer@imagingsciences.com. Imaging Sciences stated in the letter that an X-ray tube head and power supply will be provided and installed by one of their technicians. Should you have any questions regarding this information, call 215-622-1545.
Quantity in Commerce 1
Distribution X-ray tube and power supply were distributed to one consignee: Dr. Alan D'Allessandro, 2500 W. Higgins Road, Suite 665, Hoffman Estates, IL 60169
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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