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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64

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  Class 2 Device Recall Brilliance 64 see related information
Date Initiated by Firm July 03, 2018
Create Date April 13, 2019
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-1143-2019
Recall Event ID 80640
510(K)Number K033326  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance 64, 728231

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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Code Information 10011  95620  10436  95486 95391  95838  95807  95621 10521 10255  10006  10715 10275  10616   
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Ms. Holly Wright Lee
440-483-2015
Manufacturer Reason
for Recall		 Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
FDA Determined
Cause 2		 Device Design
Action On June 29. 2018, the firm sent Customer Information Letters to affected customers. The letter informed customers that Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. Customers were advised to review the user documentation provided with your system related to Quality Assurance checks. If artifacts are detected during review of the images produced by these checks, and are not removed with the recommended steps identified within your user documentation, please contact your service representative before resuming clinical use.
Quantity in Commerce 14
Distribution Distributed only to China and UK.
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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