Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Publicado el 1 de febrero de 2017 · Inicio del retiro: 19 de febrero de 2016
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Villa Radiology Systems LLC
- Distribuidor
- 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
- Lote
- 06040078 07030172 06090116 06110138 07010149 07020158 07020162 07020163 07020165 07030168 07030171 07040206 09090605 10100752 06060086 06100127 09010566 08020473 11100873 15041446
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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