Home / Recalls / Medical Devices
Villa Radiology Systems LLC recalls Villa Sistemi Rotograph EVO 3D X-ray
Recalled November 18, 2015 · FDA recall Z-0128-2016 · Villa Radiology Systems
Hazard
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). · FDA Class II
Units
Rotograph EVO 3D - 8 installed
Sold at
US Distribution
Description
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).
Product
Villa Sistemi Rotograph EVO 3D X-ray
Manufacturer(s)
Villa Radiology Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →