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Villa Radiology Systems LLC recalls Owandy Radiology I -MAX Touch 3D X-ray
Recalled November 18, 2015 · FDA recall Z-0129-2016 · 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
I-MAX Touch 3D- 6 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
Owandy Radiology I -MAX Touch 3D X-ray
Manufacturer(s)
Villa Radiology Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →