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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance BigBore Oncology CT

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  Class 2 Device Recall Brilliance BigBore Oncology CT see related information
Date Initiated by Firm February 23, 2017
Create Date March 20, 2017
Recall Status1 Terminated 3 on February 26, 2019
Recall Number Z-1492-2017
Recall Event ID 76683
510(K)Number K033357  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance BigBore Oncology CT - 728243
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. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Code Information System Serial Number - 76002, 76008, 76010, 76011, 76016, 76020, 76021, 76022, 76023, 76024, 76025 
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
When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
FDA Determined
Cause 2
Software design
Action Philips sent an Urgent Field Safety Notice dated February 24, 2017, to all affected consignee's via certified mail with returned receipts for tracking purposes. Philips Key Market representatives will distribute the notices internationally. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Implementation of the software update will be monitored. Consignees requiring further information or support concerning this issue were instructed to contact their local Philips representative. For North America and Canada, contact the Customer Care Solutions Center at 1-800-722-9377.
Quantity in Commerce 11
Distribution Worldwide Distribution - US to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, Turkey, & United Kingdom.
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.