Z-1065-2017 Class II Ongoing
FDA device recall Z-1065-2017 was initiated by Villa Radiology Systems LLC on February 19, 2016 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 66 distributed in US.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- February 19, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 distributed in US
Product Description
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
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.
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
Code Information
08090531 09090591 10040680 15051450 11020798