FDA Device recall Z-2160-2013
Juno DRF System
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of Juno DRF System by Villa Radiology Systems, citing 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 dis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2160-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-02 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Villa Radiology Systems |
| Distribution | AL, AZ, CA, CT, IA, IL, IN, MA, MD, MI, MO, MS, NY, OH, PA, UT |
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
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
Identifiers
| code_info | PN 709020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2160-2013%22
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