Food, drugs, devices › Villa Radiology Systems LLC
Device recall: Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
FDA enforcement event 73459 is a device recall by Villa Radiology Systems LLC of Oxford, CT, initiated 19 Feb 2016 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Villa Radiology Systems LLC has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Villa Radiology Systems LLC, Oxford, CT.
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…"
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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1063-2017 | Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | 66 distributed in US | Class II | Ongoing | 1 Feb 2017 |
| Z-1064-2017 | Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | 66 distributed in US | Class II | Ongoing | 1 Feb 2017 |
| Z-1065-2017 | Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | 66 distributed in US | Class II | Ongoing | 1 Feb 2017 |
| Z-1066-2017 | Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | 66 distributed in US | Class II | Ongoing | 1 Feb 2017 |
Context
Other enforcement events for Villa Radiology Systems LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Aug 2015 | Villa Sistemi Rotograph EVO 3D X-ray | Device | Class II | 2 |
| 14 Dec 2014 | Juno DFR X-ray system | Device | Class II | 1 |
| 2 Aug 2013 | Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and | Device | Class II | 1 |
All 4 events for Villa Radiology Systems LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.