Food, drugs, devices › Villa Radiology Systems LLC
Device recall: Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and
FDA enforcement event 66024 is a device recall by Villa Radiology Systems LLC of Oxford, CT, initiated 2 Aug 2013 and classified Class II, with 1 product record.
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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 25 Jul 2016. 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
"It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6"
Distribution
"US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2160-2013 | Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures | 22 units within US | Class II | Terminated | 25 Sep 2013 |
Context
Other enforcement events for Villa Radiology Systems LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Feb 2016 | Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | Device | Class II | 4 |
| 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 |
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: "It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6"
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: "US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Jul 2016. "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.