medical Class II Updated 2018-04-25

Philips Medical Systems (Cleveland) Inc recalls Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray

Recalled Product

Ingenuity Flex - Model no. 728317, 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. : 345247 345268 345206 345248 345208 345244 345253 345257 345279 345054 345059 345067 345066 345069 345068 345085 345100 345099 345048 345047 345049 345050 345052 345051 345053 345055 345056 345057 345058 345076 345062 345060 345061 345063 345065 345064 345074 345070 345072 345071 345073 345077 345075 345078 345079 345080 345081 345082 345116 345083 345084 345086 345087 345088 345091 345092 345094 345093 345095 345096 345098 345097 345102 345101 345103 345105 345106 345104 345107 345118 345111 345108 345109 345112 345113 345114 345115 345118 345117 345119 345120 345275 345202 345210 345249 345252 345263 345266 345246 345201 345226 345211 345207 345211 345214 345215 345216 345217 345219 345224 345223 345225 345227 345230 345229 345234 345236 345242 345240 345243 345245 345251 345256 345232 345258 345261 345265 345274 345273 345272 345278 345220 345255 345205 345209 345213 345212 345221 345222 345233 345235 345239 345238 345259 345260 345231 345241 345204 345276 345277 345269 345203 345228 345250 345262 345267 345270 345228 345237 345271 345202
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