ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
Publicado el 1 de mayo de 2024 · Inicio del retiro: 23 de febrero de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc.
- Distribuidor
- Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WY and the countries of BG, BW, BA, TR, AR, CL, CN, FR, SK, CD, BH, PH, AM, CR, AF, BE, AE, AZ, AO, KR, RO, HU, HR, DK, AU, DZ, CY, PL, BO, AL, NL, CI, BR, CZ, DE, AT, ES, CO, BD, CH, IT, CA, CM, DO, EC, EG, ER, ET, FI, FO, GB, GE, GR, GT, GY, HK, HN, ID, IE, IL, IN, IQ, IR, JO, JP, KE, KW, KZ, LB, LT, LU, LV, LY, MA, MD, ME, MK, MM, MN, MU, MW, MX, MY, NG, NO, NP, NZ, OM, PA, PE, PG, PK, PT, PY, QA, RS, RU, SA, SE, SG, SI, SM, SN, SV, SZ, TH, TN, TT, TW, TZ, UA, UG, UY, UZ, VN, XK, YE, ZA, ZM, ZW.
- Lote
- REF/UDI-DI: 11335791/04056869152059, and 11653093/04056869957357. Serial Numbers: 571063 556506 555717 555502 555450 555448 552655 552659 550763 556982 556990 556996 556998 557000 557001 557002 557003 555641 555631 553876 553877 556233 557117 557122 557123 556083 556082 556080 556081 556043 556044 556045 556046 556047 555714 555285 555281 555282 555283 555286 555287 555288 555290 555289 555284 550462 550460 550461 550915 550878 573362 573314 570015 573313 573132 570258 570332 575056 570033 556390 556738 556734 556545 555666 555746 552723 553173 552986 553174 550198 550541 550310 550214 550052 550051 573202 575041 571545 570335 570288 570227 575050 575051 556510 575011 570057 570058 570028 556973 557069 556967 556974 556920 555875 556598 556514 556399 556004 555693 555107 555719 555545 555477 555429 555197 555167 555215 555144 555124 555155 553043 553161 552998 553829 553542 553435 555033 553437 553438 553302 552775 551895 551967 551970 550940 555364 555368 555622 555966 556295 556334 556462 556463 556464 556490 556724 556727 556735 556812 556885 557057 557063 557068 557127 557306 557393 570031 570118 570196 571568 573178 573343 573439 576207 576231 576245 578060 557401 557372 555951 573052 555729 557113 556508 556052 555514 555530 555166 570067 573422 578089 573392 573393 570174 573044 570066 556783 556784 556650 555611 556358 556008 556030 555109 555985 555100 555121 555793 555701 555625 555544 555390 555202 555171 552907 553037 552729 553468 552594 552937 551775 550993 550834 550294 550038 556557 556271 555967 555607 555311 552708 551574 550029 557114 557252 557364 557370 555671 550775 570349 557300 570379 570357 570364 570373 570381 557299 572027 576011 576012 570384 570351 570359 570367 570368 570387 570389 570358 570391 570352 570366 570378 570386 570388 570390 570218 570338 570353 570365 570377 570382 570383 570348 570354 570355 570356 570362 570363 570371 570372 570374 570375 570380 556997 557294 570350 570341 557292 557293 557014 557015 557239 557240 557238 557013 557236 557233 557234 557235 557237 557036 556829 556848 556827 556852 556870 556803 556869 556816 556797 556704 556703 556702 556678 556743 556744 556118 556059 555961 555963 555964 556027 556102 556006 555930 555750 555702 550365 550363 553208 553213 550303 551927 551928 551660 550325 550323 550366 550327 550283 555394 556260 557011 557012 557243 557326 570344 570345 570346 570361 570385 572029 572031 572032 572033 572043 573459 577000 556958 556928 556899 556706 556616 556110 556278 556218 555437 555902 551866 555660 556953 556656 550822 552635 550751 550562 573336 571058 556196 556204 556202 556201 556203 556213 556156 555899 555907 550614 550483 550095 610026 610089 610090 610029 610081 610056 610059 610046 610047 610048 610049 610070 552189 610052 557201 557408 610069 610027 610057 610068 610060 610061 610038 610054 610055 557203 557429 557428 557174 610042 610058 557417 557414 557430 551817 552183 610025 610045 610044 610041 610043 557412 610023 610040 610024 610033 553372 553869 610005 610034 610035 610036 551821 610028 610019 610018 610011 610012 610020 610017 610014 610015 610010 610016 557163 557394 610013 610008 610009 610006 610007 557427 557200 557421 557422 557191 557407 557197 557406 557195 557396 557378 557382 557383 557387 557388 557175 553714 557373 557173 557170 557199 557156 557194 557196 553712 553722 557155 557168 557169 557172 557202 557007 557035 553716 553717 551547 553720 553730 553733 553868 553898 553731 553713 551083 554063 550991 553954 553955 553718 553692 553688 551080 553736 553732 553880 553881 553719 553737 553651 553709 553726 553735 553371 551051 553860 553710 553715 551840 551841 553734 553661 553660 553711 553669 553672 550935 552534 551823 551064 553517 551073 550942 552503 551849 551090 551075 551050 553349 551089 553249 553346 553343 551079 551081 551066 551688 552223 551078 550928 550987 551058 552506 552993 552510 551514 551555 551045 551054 551801 552532 552224 550968 551095 550966 550982 550962 550466 550996 55252
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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