Recall Z-1065-2017— Villa Radiology Systems LLC

Name: FDA recall Z-1065-2017
Creator: U.S. Food and Drug Administration
Published: 2016-02-19

Class II · Ongoing

Class II FDA medical device recall by Villa Radiology Systems LLC, initiated 2016-02-19. It names one FDA 510(k) clearance: K050190. Product: Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.. Reason: 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..

Recalling firm: Villa Radiology Systems LLC
Classification: Class II
Status: Ongoing
Initiated: 2016-02-19
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

Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

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.

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