FDAFDA · Alimentos y medicamentos·N.º oficial Z-0189-2018
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished REF 400-0100.08-R; CORE Imaging System REF 400-0100.02 For intravascular ultrasound imaging.
Publicado el 6 de diciembre de 2017 · Inicio del retiro: 3 de noviembre 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
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Volcano Corporation
- Distribuidor
- Worldwide distribution including US nationwide and Canada, AE, AT, AU, BD, BE, BG, BR, CH, CL, CN, CY, DE, DK, EG, ES, FR, GB, HU, IE, IL, IN, IT, JO, JP, KW, KR, LB, MA, MX, MY, NL, NO, PA, PK, PL, PT, QA, RO, RU, SA, SE, SG, SK, Sri Lanka, TH, TW, UAE, UK, ZA,
- Lote
- Version v3.5 software; Serial Numbers - 121020092284 103020086507 121070065001 103070097001 103070103001 103020087167 121070003001 103020092291 121020089611 103020086243 103020096244 103070057001 121020091839 121020093104 103020087187 103060028001 103060031001 103060046001 103060062001 121000504001 103070035001 121020084117 103020086808 103070010001 103070131001 121020088317 121020095839 103020085911 103020085961 103020086037 103020086161 103020088008 103020097146 121020086872 121020091918 103020084248 103020084403 103020084446 121020084118 121020094522 121020083765 121020089513 103020091063 103020088002 121020088313 121020088314 121020088315 121020088001 103020083854 103000596001 103000597001 103020084875 103020095013 103060404001 103070029001 121020084415 121020088469 121070056001 121070057001 121070046001 103020083200 121020089671 103070036001 103070037001 121070041001 121070042001 121020083595 121020084767 103020092827 121020085705 121020093100 121020091471 103070069001 103020087956 121020084507 103020084133 121070001001 121070058001 103020090806 103020091107 103020088815 103070114001 103070115001 103070140001 103070141001 103020088818 103070148001 103070149001 121020084123 121020084124 121020088216 121020089333 121020095380 103020092277 103020092335 103020092385 103020091752 103020094264 103020096245 103020098272 121020090883 121020095394 121020083335 121020095451 103020089017 103020091348 103020092638 121020091914 121060315001 121060316001 103020092278 103020083301 103020090360 103020090458 121020089943 121020095609 103020094733 121020092725 103020093222 103020093296 103020095341 121020083594 121070047001 121020088470 103020083291 103020083292 103020083294 103020083295 121020095393 103020089299 103070129001 103070130001 121020084113 121020091797 103020092398 103020092457 121020095398 103020094499 103070014001 103020083365 103020087231 121020088215 121020088217 103020089290 103020089554 103020090803 103020083957 121020092213 121070020001 103070042001 103020086571 103070068001 121070033001 103070155001 121070070001 103020093698 103020090098 121020085346 121070073001 121020084906 103020091868 103020092280 121070022001 103020096235 103020096370 103020096427 103070099001 103070100001 103020091745 103020096527 121020083764 121020090289 121020090290 06804339001 103020085430 121020083334 121020091915 103070121001 103020085465 103020091968 121020084127 103020090530 103070105001 103020091338 121020092678 103020095345 103020095962 103020095965 103020096246 103020096372 121020092056 121070039001 121020091516 103070013001 103070017001 121020088468 121020089427 121020087212 103020083329 103070143001 103070144001 121070071001 103070021001 103070151001 103070152001 103070153001 103070154001 121000276001 103020093735 103070080001 103070008001 103070002001 103070005001 103020083881 103020083896 103020085217 103020085611 103020090069 121020087948 121020095603 121020095402 121020095834 121020085707 121020091917 121020095399 121020093313 121020086056 103020083137 121020083481 103020090807 103020096524 121020085956 102120012001 121070006001 103020091577 103020083176 121020085575 121060351001 121070062001 121060365001 121070013001 103070070001 103070071001 121070043001 103020091062 103020092639 103020093700 103020093898 103020093918 103020094353 103020085108 103020085334 103020089552 103020089555 103020091478 121070019001 121020083075 103020087140 103070032001 103070033001 121020092205 103020087262 121070028001 103020087831 103020084130 06802235001 103020086809 103020086810 121020091908 103020091109 103020095504 121070055001 121020090293 121020090646 121020090649 103070074001 103070076001 103070078001 103070011001 103020092272 103020092275 103020092276 121070014001
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.