FDA (Devices) recall action 73459
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Villa Radiology Systems LLC is recalling 66 Apollo DRF multi-function x-ray systems because a chain of faults led to an injury involving inadvertent movement activation.
Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.
Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.
Villa Radiology Systems LLC is recalling 66 Apollo EZ multi-function x-ray systems because a chain of faults caused an injury to a user.