Recall Z-1079-2015— Villa Radiology Systems LLC

Name: FDA recall Z-1079-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-14

Class II · Terminated

Class II FDA medical device recall by Villa Radiology Systems LLC, initiated 2014-12-14, terminated 2017-03-16. It names one FDA 510(k) clearance: K050190. Product: Juno DFR X-ray system. Reason: The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality.

Recalling firm: Villa Radiology Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2014-12-14
Terminated: 2017-03-16
Firm location: Oxford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K050190 — APOLLOVilla Sistemi Medicali S.P.A.·cleared 2005-03-25

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

Juno DFR X-ray system

Reason for recall

The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality

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