Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
FDA Recall Z-1064-2017 · Posted None
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Recalling FirmVilla Radiology Systems LLC
Recall StatusOpen, Classified
Product CodeKXJ
Date Initiated2016-02-19
Product Quantity66 distributed in US
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.
Firm 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.
Root Cause
Device Design
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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