Villa Radiology Systems LLC: Medical Device Recall in 2015 - (Recall #: Z-0129-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Owandy Radiology I -MAX Touch 3D X-ray

Product Classification:

Class II

Date Initiated: August 5, 2015

Date Posted: November 18, 2015

Recall Number: Z-0129-2016

Event ID: 71958

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).

Status: Terminated

Product Quantity: I-MAX Touch 3D- 6 installed

Code Information:

p/n 9306251191 and 9306651191

Distribution Pattern:

US Distribution

Voluntary or Mandated:

Voluntary: Firm initiated