Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of… — Class II medical device recall Z-1065-2017
Ongoing recall by Villa Radiology Systems LLC, reported 2017-02-01, distributed in AL, AZ, CA, CO, CT, DC, FL, IA…. The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a
| Recall number | Z-1065-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Villa Radiology Systems LLC, Oxford, CT, United States |
| Recall initiated | 2016-02-19 |
| Classified | 2017-01-20 |
| Reported by FDA | 2017-02-01 |
| Distributed | 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 |
| Quantity | 66 distributed |
| Reason classes | labeling |
| Model numbers | 9784220831 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1065-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.