Siemens Medical Solutions USA, Inc.: ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G

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: 628 Lot/code info: UDI-DI: 04056869251264. Serial Numbers: 560821 560366 560250 560251 560311 560490 560489 560069 560207 560107 560055 560051 560801 560478 560450 560379 560349 560152 561113 561137 560474 560598 560672 560674 560603 561007 560587 560284 561272 560553 560639 561024 561025 561274 560746 560747 562194 561279 561326 562155 562161 562199 562141 562146 562195 562160 562211 562147 560514 562051 560552 562124 560883 562128 560875 562066 560498 562061 562037 562052 562038 562024 561452 562003 561472 561354 561386 561465 561466 561467 560512 560656 561395 560554 561391 561271 561317 561315 561347 561273 561287 560756 561235 560777 561263 561264 561262 561224 560872 560802 560887 560888 560882 560881 561213 560810 560739 560741 560755 560754 560785 561164 560886 560779 560884 561047 560885 561045 560880 560791 560620 560551 561021 561081 561034 561035 560510 560869 560792 561043 561046 561040 561048 561027 561029 561037 560776 560650 561006 560508 560752 560804 560835 561003 560641 560649 560855 560856 560805 560813 560814 560809 560763 560783 560767 560769 560770 560774 560793 560661 560794 560696 560738 560740 560635 560703 560692 560530 560582 560632 560634 560596 560606 560622 560610 560516 560589 560513 560525 560533 560507 560515 560266 560522 561309 560188 560657 560837 560612 561166 561167 560216 560834 560651 560652 560654 560426 560270 560123 560108 561015 561001 560168 561285 560280 560682 560753 560762 560710 560636 560644 560633 560535 560062 560472 560473 560427 560428 5603

UPC codes

04056869251264

Source

Official record: FDA (Device enforcement) ↗

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