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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Medical Systems Brilliance iCT

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  Class 2 Device Recall Philips Medical Systems Brilliance iCT see related information
Date Initiated by Firm November 25, 2016
Create Date January 11, 2017
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-1004-2017
Recall Event ID 76021
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance iCT

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 Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Holly Wright Lee
440-483-7600
Manufacturer Reason
for Recall		 Failure to correctly document the installation of four M12 Bolts into the system rotor.
FDA Determined
Cause 2		 Employee error
Action Philips sent a Customer Information Letter to their customer. The letter identified the affected product, problem description and actions to be taken by customers. For further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377).
Quantity in Commerce 1
Distribution The one system was distributed in Canada. There were no government or US 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.
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