Device product
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Z-1065-2017
Product summary
- Event
- Event 73459
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 66 distributed in US
- Official record key
device-enforcement:Z-1065-2017
Official wording
Reason: 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.
Code information: 08090531 09090591 10040680 15051450 11020798
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
Derived failure modes
-
Unknown
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.