Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- int

Hazard / Issue

Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Serial Numbers: SY-01-00358350-11 SY-01-00048100 SY-01-01421950-151 SY-01-0080093778 SY-01-00745300 SY-01-0080087818 SY-01-00358350-16 SY-01-00544800 SY-01-01333000-34 SY-01-07012810 SY-01-0080082385 SY-01-0080078513 SY-01-07059500 SY-01-01333000-07 SY-01-01333000-20 SY-01-01333000-34 SY-01-07302600 SY-01-00127000 SY-01-07038976 SY-01-01487000-02 SY-01-00272120 SY-01-00349940 SY-01-00233520 SY-01-0080087409 SY-01-00233710 SY-01-00358350-03 SY-01-00236550 SY-01-0052282 SY-01-00254800-02 SY-01-000254800 SY-01-00269450 SY-01-07039120-01 SY-01-00272350-01 SY-01-00272410 SY-01-00106300 SY-01-00316710 SY-01-00277570-04 SY-01-00322350 SY-01-00322360 SY-01-07055566 SY-01-00493810-327 SY-01-01487000-01 SY-01-07060430-01 SY-01-80096794 SY-01-0079187 SY-01-09003000 SY-01-00465550 SY-01-00493810-112 SY-02-01138010-47 SY-01-00463100 SY-01-00493810-340 SY-01-0080092404 SY-01-00586560 SY-01-00591100 SY-01-00593500-01 SY-01-0080076025 SY-01-01447400-01 SY-01-00493810-155 SY-01-07127057 SY-0180097541 SY-01-00605610 SY-01-00616700-02 SY-01-0080053255 SY-01-0080080176 SY-01-00658580-01 SY-01-00228750-01 SY-01-01687500 SY-01-0080057825 SY-01-00693860 SY-01-0080071248 SY-01-00798760 SY-01-00804700-01 SY-01-0074955 SY-01-0080055290 SY-01-0080074389 SY-01-07160281 SY-01-0077489 SY-01-00873500 SY-01-07163410 SY-0080053050-001 SY-01-00103613 SY-01-00899150 SY-01-00816310 SY-01-0080094741 SY-01-07182322 SY-01-00971200 SY-01-0080092600 SY-01-80097226 SY-01-01034770 SY-01-09625000 SY-01-01072260 SY-01-01446300 SY-01-00769050-01 SY-01-01079071 SY-01-00493810-137 SY-01-00439700-10 SY-02-00858500 SY-01-07274900-01 SY-01-00493810-157 SY-01-01421950-26 SY-01-01134010 SY-01-00082610 SY-01-07242000 SY-01-00493810-300 SY-01-00949090 SY-01-00493810-97 SY-01-0080073752 SY-01-00322221 SY-01-05050280-60 SY-01-08131000 SY-01-01255600-03 SY-01-01272111 SY-01-07264334 SY-01-01401510-02 SY-01-80060398 SY-01-00493810-54 SY-01-01430700 SY-01-01447400 SY-01-01451260 SY-01-01318310 SY-01-00529515 SY-01-01327350 SY-01-01482450 SY-01-01489350 SY-01-01558860 SY-01-01573510 SY-01-00822790 SY-01-0080087769 SY-03-00070210 SY-01-07214790 SY-01-01717500-15 SY-01-00398300-10 SY-01-0080072627 SY-01-0080055858 SY-01-0080055213