FDA (Devices) recall action 75125
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens is recalling 101 Syngo Plaza PACS systems because a suffix on DICOM images may indicate that displayed measurements differ from actual values.
Siemens is recalling 101 Syngo.Plaza VB 10 A image processing systems because a suffix on DICOM images may indicate that displayed measurement values differ from real values.