FDA (Devices) recall action 85216
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.
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
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.
Synaptive Medical Inc is recalling 28 units of ImageDrive Clinical software due to a defect that degrades mammogram image quality, potentially leading to misdiagnosis.
Synaptive Medical is recalling ClearCanvas RIS/PACS software because a defect affects mammogram image quality, potentially leading to misdiagnosis.