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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Brilliance Big Bore (Oncology)

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  Class 2 Device Recall Philips Healthcare Brilliance Big Bore (Oncology) see related information
Date Initiated by Firm February 08, 2018
Create Date April 17, 2018
Recall Status1 Terminated 3 on April 09, 2020
Recall Number Z-1410-2018
Recall Event ID 79666
510(K)Number K033357  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system

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 Serial No: 75070 750002 75046 750002 75114 75118 75127 75130 750021 75128 750015 75052 75039 75027 75067 75041 75028 75036 75034 75029 75031 75047 75048 75057 75054 75049 75056 75053 75058 75062 75064 75066 75068 76023 75037 76022 76024 75104 75111 75126 75112 750006 76008 750014 75059 750005 75061 75107 750007 750008 75129 750013 75120 750028 750016 750022 750024 750025 750026 750029 75115 75131 750023 7524 75119 76002 75121 75108 75102 75101 75108 75100 750004 75132 750019 750020 75063 75044 750001 75113 750012 75035 75038 75051 75051 750010 750017 75055 75060 75055 750027 75105 75042 75032 75069 75040 75116 75065 75050 75065 76011 76010 76016 76020 76021 750018 
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Ms. Holly Wright Lee
440-483-2950
Manufacturer Reason
for Recall		 Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
FDA Determined
Cause 2		 Software design
Action The recalling firm notified customers of the recall on February 8, 2018, via Urgent Field Safety Notice. The notice advised customers of the issue and affected products and lot numbers. Customers were advised that once the E-stop has been closed, the operator/technologist must initate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Customers were informed that a Field Service Engineer would contact them to schedule site updates to correct the issue. Customers who need further information or support were advised to contact their local Philips representative. Additionally, they may contact the Customer Care Solutions Center (1-800-722-9377.
Quantity in Commerce 106
Distribution Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
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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