FDA (Devices) recall action 94090
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
The agency’s own wording, quoted from the enforcement report.
Synapse PACS Version 7.1.000 medical imaging software produces incorrect measurements when Secondary Capture 2D images without pixel spacing are combined with Breast Tomo Series data.
FUJIFILM is recalling Synapse PACS Version 7.2.100 because the medical imaging software produces incorrect measurements when analyzing certain breast images. Affected healthcare facilities using this software version should verify measurement accuracy in their systems.
FUJIFILM's Synapse PACS Version 7.2.200 produces incorrect measurements when analyzing certain breast imaging scans without pixel spacing data. This measurement error could affect diagnostic accuracy.
Synapse PACS Version 7.1.000US may produce incorrect measurements when Secondary Capture 2D images lack pixel spacing information in the DICOM header. The affected software is installed in healthcare facilities worldwide, including the United States and Puerto Rico.
FUJIFILM's Synapse PACS version 7.3.000 software produces incorrect measurements when secondary capture images without pixel spacing are combined with breast tomosynthesis series. No illnesses or injuries reported.
FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.