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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Philips Healthcare Brilliance Big Bore (Radiology) 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-1411-2018
Recall Event ID 79666
510(K)Number K033357  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance Big Bore (Radiology) - Model no. 728244, 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: 76106 760012 760002 76075 75123 76034 76052 76088 76079 76007 76104 76082 76086 76077 76083 76013 76009 76034 76081 76014 76074 76030 76028 76054 76045 76047 76057 76068 76071 76069 76092 76073 760015 760006 760011 750003 75125 76004 76027 760008 760009 760020 76089 75033 75122 760014 760013 760004 76067 760007 75110 760017 760001 760005 760016 760019 760019 75043 760010 75030 75043 760018 75106 75117 75124 750011 76043 76062 76072 760003 76003 76018 76017 76005 76001 76078 76087 76019 76080 76090 76084 76006 76012 76015 76026 76036 76038 76037 76039 76035 76031 76033 76032 76107 76040 76042 76046 76041 76056 76055 76050 76044 76049 76053 76048 76051 76058 76061 76065 76063 76064 76060 76059 76066 76070 76076 76085 76091 76040 
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 119
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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