Reported Jul 8, 2020 · Ongoing
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160
Is this the product you have?
- Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
- Lot codes and dates
- Serial Numbers
135 of 135 codes
SY-01-00358350-11SY-01-00048100SY-01-01421950-151SY-01-0080093778SY-01-00745300SY-01-0080087818SY-01-00358350-16SY-01-00544800SY-01-01333000-34SY-01-07012810SY-01-0080082385SY-01-0080078513SY-01-07059500SY-01-01333000-07SY-01-01333000-20SY-01-01333000-34SY-01-07302600SY-01-00127000SY-01-07038976SY-01-01487000-02SY-01-00272120SY-01-00349940SY-01-00233520SY-01-0080087409SY-01-00233710SY-01-00358350-03SY-01-00236550SY-01-0052282SY-01-00254800-02SY-01-000254800SY-01-00269450SY-01-07039120-01SY-01-00272350-01SY-01-00272410SY-01-00106300SY-01-00316710SY-01-00277570-04SY-01-00322350SY-01-00322360SY-01-07055566SY-01-00493810-327SY-01-01487000-01SY-01-07060430-01SY-01-80096794SY-01-0079187SY-01-09003000SY-01-00465550SY-01-00493810-112SY-02-01138010-47SY-01-00463100SY-01-00493810-340SY-01-0080092404SY-01-00586560SY-01-00591100SY-01-00593500-01SY-01-0080076025SY-01-01447400-01SY-01-00493810-155SY-01-07127057SY-0180097541
- Serial Numbers
- Amount recalled
- 135 units
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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