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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Ingenuity Core

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  Class 2 Device Recall Philips Ingenuity Core see related information
Date Initiated by Firm June 07, 2017
Create Date October 31, 2018
Recall Status1 Terminated 3 on July 03, 2019
Recall Number Z-0309-2019
Recall Event ID 81403
510(K)Number K171850  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Core (Model No. 728321), Software version 4.1.6

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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Code Information software versions 4.1.6
Recalling Firm/
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Ms. Holly Wright Lee
Manufacturer Reason
for Recall
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
FDA Determined
Cause 2
Software design
Action The recalling firm sent Customer Information letters dated June 7, 2017, to affected customers. The letter notified customers of the product issue. Customers were instructed to determine whether they had a potentially affected system by checking the software version of their device. Customers were reminded that the "Impressions" section of the report is not intended for diagnostic use. Users should instead focus on the total calcium score shown in the "Findings" section, the coronary artery score(s) and/or the "Age and Gender" graph as identified in the Instructions for Use (IFU). The firm sent a follow-up dated July 3, 2018, to inform customers that software updates had been released which resolved the issue. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377 and follow the prompts).
Quantity in Commerce 1890
Distribution US Nationwide Distribution
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 (Cleveland) Inc.