Juno DRF System — Class II medical device recall Z-2160-2013
Terminated recall by Villa Radiology Systems LLC, reported 2013-09-25, distributed in AL, AZ, CA, CT, IA, IL, IN, MA…. It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (1
| Recall number | Z-2160-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Villa Radiology Systems LLC, Oxford, CT, United States |
| Recall initiated | 2013-08-02 |
| Classified | 2013-09-13 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2016-07-25 |
| Distributed | AL, AZ, CA, CT, IA, IL, IN, MA, MD, MI, MO, MS, NY, OH, PA, UT |
| Quantity | 22 units |
Product
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
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
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-2160-2013. 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.