Villa Radiology Systems LLC: Medical Device Recall in 2017 - (Recall #: Z-1065-2017)

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:

Apollo DRF: Model: 9784220831 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-1065-2017

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:

08090531 09090591 10040680 15051450 11020798

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