Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
Brand
Fujifilm Medical Systems U.S.A., Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Fujifilm Medical Systems U.S.A., Inc. is recalling Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synap due to Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice lo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Fujifilm issued URGENT: Medical Device Correction and Removal notification via FedEx standard overnight mail on May 22, 2020, stating reason for recall, health risk and action to take: recommending that you do not perform Tomosynthesis on these views until the correction is applied. FUJIFILM is providing hotfixes for Synapse PACS Versions 5.5, 5.7.0, and 5.7.1 to resolve these issues. Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633). Cmplete and return the Field Action Verification Form Providing the response with the information requested is essential for ensuring appropriate action is taken. Contact field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at jeffrey.wan@fujifilm.com, if you have any further questions regarding this field action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026