FDAFDA · Alimentos y medicamentos·N.º oficial Z-1875-2017
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Publicado el 3 de mayo de 2017 · Inicio del retiro: 30 de marzo de 2017
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
When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Ethiopia, Egypt, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Venezuela, Vietnam and United Kingdom,
- Lote
- US serial numbers: 200113 200245 200394 200695 200706 200715 200935 201159 201256 201916 202076 202551 202559 202584 202587 202600 202626 202937 203212 205736 205850 206286 206919 206949 207048 207073 207087 207096 207099 207551 207552 207560 207566 207572 207648 207713 208114 208142 208153 208984 209481 210012 210017 210061 210128 210143 210157 210163 210173 210188 210241 210274 210324 210334 210439 210508 210569 210584 210664 210665 210666 210679 210703 210735 210737 210742 210744 210747 210753 210811 210832 210861 210873 210979 210981 211018 211026 211070 211093 211124 211138 211158 211167 211244 211249 211302 211316 211325 211335 211336 211337 211338 211340 211347 211352 211354 211355 211357 211362 211375 211460 211480 211499 211513 211549 211581 211626 211627 211637 211639 211643 211647 211648 211649 211650 211653 211659 211666 211715 211717 211720 211723 211732 211733 211745 211750 211751 211752 211767 211769 211770 211778 211782 211788 212069 212070 212082 212083 212084 212092 212093 212094 212209 212210 212211 212212 212215 212216 212217 212218 212219 212220 212242 212243 212244 212245 212246 212247 212248 212249 212250 212251 212253 212254 212255 212257 212296 212298 212299 212308 212309 212311 212321 212334 212343 212344 212345 212346 212364 212385 212416 212417 212427 212457 212479 212492 212497 212541 212542 212543 212544 212545 212546 212547 212548 212550 212551 212552 212554 212582 212584 212585 212586 212588 212589 212591 212592 212597 212599 212601 212602 212603 212604 212605 212607 212612 212613 212614 212615 212617 212618 212619 212622 212623 212624 212630 212632 212635 212640 212641 212642 212644 212645 212646 212647 212649 212650 212654 212664 212665 212666 212668 212672 212673 212674 212675 212676 212678 212679 212681 212682 212683 212685 212686 212687 212691 212697 212698 212702 212704 212705 212706 212715 212716 212721 212722 212723 212725 212730 212732 212736 212740 212741 212746 212750 212751 212754 212755 212756 212758 212762 212764 212766 212767 212768 212769 212773 212774 212775 212777 212778 212782 212783 212785 212786 212787 212788 212790 212791 212792 212794 212795 212797 212800 212801 212803 212804 212806 212808 212809 212812 212815 212816 212838 212839 212850 212853 212854 212856 212858 212859 212860 212862 212863 212864 212865 212868 212870 212873 212875 212876 212878 212879 212880 212883 212889 212890 212893 212896 212897 212910 212917 212918 212919 212923 212925 212927 212928 212933 212937 212944 212952 212954 212955 212956 212964 212965 212968 212969 212976 212977 212981 212983 212984 212987 212992 212993 213000 213004 213012 213015 213018 213021 213022 213023 213024 213025 213027 213028 213029 213034 213035 213040 213044 213046 213057 213058 213063 213064 213066 213067 213068 213069 213070 213071 213072 213073 213074 213075 213076 213078 213080 213081 213082 213088 213089 213094 213097 213098 213100 213102 213129 213132 213135 213136 213137 213140 213141 213142 213143 213145 213146 213147 213148 213149 213151 213152 213153 213154 213155 213156 213162 213164 213172 213173 213174 213175 213176 213177 213178 213179 213180 213185 213189 213190 213196 213199 213200 213204 213208 213214 213220 213221 213223 213224 213225 213226 213229 213232 213233 213235 213238 213240 213241 213242 213243 213244 213245 213246 213247 213250 213251 213252 213254 213257 213260 213262 213264 213265 213267 213271 213272 213273 213274 213276 213279 213280 213282 213283 213284 213285 213286 213288 213291 213293 213294 213295 2132
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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