Recall Z-1063-2017 ยท KXJ Table, Radiologic
Villa Radiology Systems LLC
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
| Date | Feb 19, 2016 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Consignees were notified of the recall via letter starting on 2/19/16. The letter explains the issue and actions to be taken by the consignee and manufacturer. |
| Quantity | 66 distributed in US |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050190 | APOLLO Villa Sistemi Medicali S.P.A., Mar 25, 2005 |