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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Ingenuity Core

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  Class 2 Device Recall Philips Healthcare Ingenuity Core see related information
Date Initiated by Firm July 20, 2016
Create Date August 25, 2016
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-2657-2016
Recall Event ID 74820
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Core, Model number 728321

Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Code Information 728321 -- Ingenuity Core  310004 310005 310012 310016 310020 310021 310027 310028 310033 310034 310041 310044 310045 310057 310061 310065 310072 310074 310076 310077 310078 310094 310099 310100 310103 310105 310117 310120 310122 310135 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs. Holly Wright Lee
440-483-2015
Manufacturer Reason
for Recall		 After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
FDA Determined
Cause 2		 Software Design Change
Action Customers were sent a letter dated July 28, 2016 informing them of the problem, under what circumstances it can occur and the actions that the customer can take to minimize the effect of the problem. The letter also includes the actions planned by Philips to correct the problem. Philips plans on releasing a field change order (FCO) to correct the affected systems. If you need any further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377).
Quantity in Commerce 30
Distribution US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
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 = PHILIPS MEDICAL SYSTEMS, INC.
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