Villa Radiology Systems LLC: Medical Device Recall in 2017 - (Recall #: Z-1064-2017)

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: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 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-1064-2017

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:

06040078 07030172 06090116 06110138 07010149 07020158 07020162 07020163 07020165 07030168 07030171 07040206 09090605 10100752 06060086 06100127 09010566 08020473 11100873 15041446

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