Villa Radiology Systems LLC: Medical Device Recall in 2017 - (Recall #: Z-1063-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

Product Classification:

Class II

Date Initiated: February 19, 2016

Date Posted: February 1, 2017

Recall Number: Z-1063-2017

Event ID: 73459

Reason for Recall:

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

Status: Ongoing

Product Quantity: 66 distributed in US

Code Information:

10110770 11030805 11030806 11070845 11070848 11070849 11090864 11110900 12020978 12020982 12030999 12041003 12061014 12061018 12061020 12081040 12091074 12101104 12121186 12121187 13031215 13101263 14021301 14031313 14041321 14051332 14071353 14081359 14091368 14091371 14121400 14121403 15021426 15031440 15041444 15091473 15091478 15101484 15101487

Distribution Pattern:

AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI

Voluntary or Mandated:

Voluntary: Firm initiated