FDA (Devices) recall action 84642
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.
Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.
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.
MEDTECH SAS is recalling 39 units of the ROSA One 3.1 Brain Application because cross-sectional images may not display properly, potentially compromising surgery planning.
Medtech SAS is recalling ROSA Brain 3.0 software because cross-sectional images may not display properly, potentially compromising surgery planning.