Z-0128-2016 Class II Terminated
FDA device recall Z-0128-2016 was initiated by Villa Radiology Systems LLC on August 5, 2015 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated March 22, 2017). Affected quantity: Rotograph EVO 3D - 8 installed.
Recall Details
- Product Type
- Devices
- Report Date
- November 18, 2015
- Initiation Date
- August 5, 2015
- Termination Date
- March 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Rotograph EVO 3D - 8 installed
Product Description
Villa Sistemi Rotograph EVO 3D X-ray
Reason for Recall
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).
Distribution Pattern
US Distribution
Code Information
p/n 9307251291, 9307351291, 9307651291