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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Ingenuity Core 128 CT Xray system

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  Class 2 Device Recall Philips Healthcare Ingenuity Core 128 CT Xray system see related information
Date Initiated by Firm April 14, 2015
Create Date December 12, 2015
Recall Status1 Terminated 3 on September 23, 2020
Recall Number Z-0407-2016
Recall Event ID 71926
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
Code Information 728323
Recalling Firm/
Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
Manufacturer Reason
for Recall
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action Philips Healthcare Planned Action: 1. Philips Healthcare will contact customers and initiate a software update to correct the defect. 2. Philips Healthcare engineers will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Philips Healthcare will implement this CAP by April 1, 2016. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.
Quantity in Commerce 105
Distribution Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mayanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Republic of Korea, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tanzania, Tunisia, Turkey, United Arab Emirates, Uzbekstan and Vietnam.
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.