Siemens Medical Solutions USA, Inc.: ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x w

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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, Quantity: 5090 Lot/code info: 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 5508

UPC codes

04056869152059, 04056869957357

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.