FDA (Devices) recall action 98244
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.
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
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.
Prima Vera Nueva is recalling 9,656 packages (4 tamales per package) of Roasted Pumpkin & White Cheddar Tamales over potential contamination with Listeria monocytogenes.
Siemens is recalling 7 units of the LUMINOS Q.namix T fluoroscopic X-ray system because ortho images may not be flipped as preset and an image of a previous patient may be processed.