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U.S. Department of Health and Human Services

Class 2 Device Recall Ingenuity Core

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  Class 2 Device Recall Ingenuity Core see related information
Date Initiated by Firm April 01, 2016
Create Date July 01, 2016
Recall Status1 Terminated 3 on June 26, 2018
Recall Number Z-2117-2016
Recall Event ID 74427
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Ingenuity Core-Computed Tomography X-ray system

Product Usage:
The Ingenuity Core scanner is a whole body Computed Tomography X-ray system 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 Ingenuity Core,System Code #728321, Serial numbers: 310101, 310102, 310103, 310104, 310105, 310106, 310108, 310109, 310112, 310115, 310137, 333006, 333008, 333011, 333012, 333013, 333016, 333017, 333023
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-483-2015
Manufacturer Reason
for Recall		 Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Philips Medical Systems (Cleveland) Inc. sent an Urgent Field Safety Notice letter to affected customers , via certified letter with receipts returned for tracking purposes. The letter identified the affected product, problem and actions to be taken. Philips Healthcare is implementing software update version 3.5.5 to correct the problem. For questions contact your local Philips representative or local Philips Healthcare office.
Quantity in Commerce 18
Distribution US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
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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