FDAFDA · Alimentos y medicamentos·N.º oficial Z-0486-2015
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
Publicado el 10 de diciembre de 2014 · Inicio del retiro: 11 de septiembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
There is a potential issue on running Artis systems running software VC1x software if a network problem arises, the function cannot be deactivated again by pressing the "Block Radiation" key on the touch screen control. If this behavior occurs, the system image generation function is not available for patient examinations without switching the system off and back on again manually. This
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc
- Distribuidor
- Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of: United Arab Emirates, Armenia, Austria, Australia, Belgium, Bahrein ,Belarus, Switzerland, Chile, China, Colombia, Czech Republic,Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Kenya, Korea, Kazakhstan, Malaysia, Netherlands, Norway, New Zealand, Philippines, Pakistan, Poland, Palestina, Portugal, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, Vietnam and South Africa.
- Lote
- model numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 153229 153131 146669 146877 146996 157435 146663 147100 147233 147049 136077 135746 153172 135229 160313 146174 153315 153318 153317 146121 146710 146945 153992 147084 147189 147190 153335 153695 135120 135322 146679 153102 153101 146232 157660 153727 146728 146408 146409 157458 153216 146335 153779 146659 146993 153280 153648 153674 160395 153166 146898 146965 160484 135757 136513 153700 154096 135000 136562 146221 147273 157698 146871 146814 146952 147239 147030 135914 153834 146988 160348 157532 160502 146899 153194 153169 135102 146643 146650 136085 146980 146361 146365 146366 146369 146912 147036 135927 153110 146116 146164 146168 157657 160392 153890 157136 154157 153199 135209 140106 147371 153887 160115 146156 146342 146343 135986 153269 154074 157690 135935 135953 154012 147129 135841 153191 153252 135200 135201 135279 157616 153732 147210 135169 135879 160449 153274 157710 153717 153239 157560 157509 146192 157436 147081 160463 135990 154090 147267 153227 146235 153967 153655 146201 157677 153285 153234 153236 146249 146260 146277 146868 146818 146758 157528 146741 153273 153130 153129 153138 153686 146719 160139 153251 153254 146245 146217 153344 147047 157503 154095 160406 153342 140115 153328 146195 153106 153171 153197 153916 146187 146188 146189 136710 146113 146171 146173 146176 146186 146636 147042 157615 160134 160136 160106 146630 136103 157448 146766 135862 146266 157165 154086 146154 146298 146305 146908 153831 135235 135117 146267 147208 147247 135358 146219 146272 160338 146780 146274 153256 147096 160347 135920 153154 140101 147236 140205 136168 146193 146761 135148 157700 147175 153139 146637 135939 153882 146972 147078 160506 153311 135366 146327 146333 146338 153211 136568 147022 160312 147023 157602 146851 147249 147255 146410 146676 146248 146286 146292 135843 146688 146144 157168 154053 147188 147165 160488 135779 136224 153740 153709 146715 146355 160142 146293 146308 146968 147105 153863 153772 146825 146827 147304 146829 140213 160427 160455 146828 157213 146937 154079 136109 153707 135137 146946 147024 160320 146334 160435 136607 154098 136579 154073 153263 157164 153276 135309 146322 154076 146888 147172 146136 153758 160451 157559 157156 136280 136286 147164 146795 146738 146395 146324 147357 147363 147365 135413 147378 147087 146742 154156 146169 160100 146619 146357 153351 160448 153112 135144 135145 136362 153155 146856 153245 146921 157750 146263 146781 146721 146724 146860 140209 153720 146393 136318 153857 147035 157573 160493 157650 153226 146159 147193 147196 146986 157671 153939 146150 146812 157554 157555 136234 146251 153951 157713 146241 146242 146635 146323 147025 146354 146388 160391 147044 157521 153190 146727 146238 146722 160470 135421 135151 146382 160321 146753 146755 146756 147203 153290 146618 146264 146119 135264 153679 135199 136500 135760 147098 136515 135217 146139 147113 136031 136032 160376 153277 146656 160447 160471 153128 153135 153125 153134 135124 135125 136084 147107 153743 136026 146942 160481 153946 146886 147167 157696 146733 136479 147121 135179 135394 160119 153145 153868 153866 160403 135285 160404 136338 153829 146612 157488 153148 157644 157648 140219 135245 135420 146731 146809 160008 146394 146846 146855 136384 136387 136102 136488 146940 146957 153217 153639 135770 160411 136550 147243 153119 160438 146918 136005 136063 146709 153164 153304 136256 135767 136408 136508
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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