Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1064-2017 — Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

U.S. FDA — Device Enforcement · United States · 2016-02-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1064-2017
Date of alert
2016-02-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Villa Radiology Systems LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
06040078
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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