medical Class II Updated 2018-04-25

Philips Medical Systems (Cleveland) Inc recalls Brilliance Big Bore (Radiology) - Model no. 728244, Computed

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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
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