FDA Medical Device Recalls (openFDA)
Villa Radiology Systems LLC: Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
- Recall number
- Z-1065-2017
- Recalling firm
- Villa Radiology Systems LLC
- Product
- Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
- Status
- Open, Classified
- Initiated
- 2016-02-19
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- Consignees were notified of the recall via letter starting on 2/19/16. The letter explains the issue and actions to be taken by the consignee and manufacturer.
- Quantity
- 66 distributed in US
- Distribution
- 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, serial or model codes
- 08090531 09090591 10040680 15051450 11020798
- 510(k) numbers
- ["K050190"]
- PMA numbers
- not on file
- Product code
- KXJ
- Firm FEI
- 2243757
- Firm city
- Oxford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28