—#162963

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033357
Affected lot / code info: 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

Why it was recalled

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-02-08
Terminated: 2020-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162963. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.