FDA (Devices) recall action 71958
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.
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
The agency’s own wording, quoted from the enforcement report.
Villa Radiology Systems LLC is recalling six Owandy Radiology I-MAX Touch 3D X-ray units because they lack required accompanying information documents.
Villa Radiology Systems LLC is recalling eight Rotograph EVO 3D X-ray units because accompanying documents are missing, causing non-compliance with FDA regulations.