FDA-Device2015-11-18Class II
Owandy Radiology I -MAX Touch 3D X-ray
Villa Radiology Systems LLC
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).
Sold states
US Distribution
Affected count
I-MAX Touch 3D- 6 installed
Manufactured in
91 Willenbrock Rd Ste B1, N/A, Oxford, CT, United States
Products
Owandy Radiology I -MAX Touch 3D X-ray
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0129-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief