Recall Z-0129-2016— Villa Radiology Systems LLC

Name: FDA recall Z-0129-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-05

Class II · Terminated

Class II FDA medical device recall by Villa Radiology Systems LLC, initiated 2015-08-05, terminated 2017-03-22. It names one FDA 510(k) clearance: K130443. Product: Owandy Radiology I -MAX Touch 3D X-ray. Reason: 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)..

Recalling firm: Villa Radiology Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2015-08-05
Terminated: 2017-03-22
Firm location: Oxford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K130443 — I-MAX TOUCH 3DOwandy·cleared 2013-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Owandy Radiology I -MAX Touch 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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.