medical Class II Updated 2021-07-14

Siemens Medical Solutions USA, Inc recalls ARTIS pheno- angiography systems developed for single and bi

Recalled Product

ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000

Hazard / Issue

Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging (PERISTEPPING/PERIVISION), the C-arm may leave its intended travel path by up to 22 cm (9") result in canceling clinical treatment or to continue treatment on an alternative system

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software VE10B. Serial Numbers: 164138 164159 164033 164287 164282 164210 164183 164184 164311 164142 164071 164328 164034 164318 164244 164242 164306 164155 164189 164271 164277 164173 164292 164231 164057 164054 164055 164080 164132 164329 164072 164088 164190 164333 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164257 164293 164263 164298 164060 164083 164113 164021 164066 164124 164125 164279 164075 164074 164084 164086 164098 164028 164153 164330 164295 164234 164321 164270 164275 164315 164163 164158 164053 164171 164134 164253 164188 164063 164064 164299 164300 164105 164160 164024 164049 164240 164227 164228 164018 164022 164250 164061 164187 164115 164322 164269 164303 164204 164205 164211 164212 164216 164196 164168 164319 164201 164202
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