FDA Device recall Z-1065-2017
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures
- FDA Device
- Class II
- ongoing
- Published 2017-02-01
On 2017-02-01 the FDA classified a Class II recall of Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures by Villa Radiology Systems, citing 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 acce….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1065-2017 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-02-19 |
| Published | 2017-02-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Villa Radiology Systems |
| Distribution | AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, PA, PR, TN, TX, UT, WI |
Product
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
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.
Identifiers
| code_info | 08090531 09090591 10040680 15051450 11020798 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1065-2017%22
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