RecallRadar

FDA Device recall Z-1079-2015

Juno DFR X-ray system

On 2015-03-18 the FDA classified a Class II recall of Juno DFR X-ray system by Villa Radiology Systems, citing the system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1079-2015
ClassificationClass II
Statusterminated
Initiated2014-12-14
Published2015-03-18
Last updated2026-09-13 11:53 UTC
CompanyVilla Radiology Systems
DistributionAL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, MA, MD, MI, MO, MS, NY, OH, PA, TN, TX, UT

Product

Juno DFR X-ray system

Reason

The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality

Identifiers

code_infoP/N 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-1079-2015%22

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