Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Published February 1, 2017 · Recall initiated: February 19, 2016
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Villa Radiology Systems LLC
- Distributor
- 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
- Lot
- 06040078 07030172 06090116 06110138 07010149 07020158 07020162 07020163 07020165 07030168 07030171 07040206 09090605 10100752 06060086 06100127 09010566 08020473 11100873 15041446
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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