Z-1079-2015Class II

Juno DFR X-ray system

Name: Z-1079-2015 Juno DFR X-ray system
Creator: Villa Radiology Systems LLC
Published: 2014-12-14
License: https://open.fda.gov/license/

Acteon, Inc. / initiated 2014-12-14 / Terminated

FDA source

Villa Radiology Systems LLC began a recall of Juno DFR X-ray system on 2014-12-14. FDA classified it as Class II and gives the reason as "The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1079-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-14
Posted: 2015-03-06
Terminated: 2017-03-16
Recalling firm: Acteon, Inc.
Product: Juno DFR X-ray system
Product code: KXJ Table, Radiologic
Reason for recall: The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
FDA root cause: Radiation Control for Health and Safety Act
Action: Planned Action by the firm: 1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge. 2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR The system shall be modified upgrading the generator power firmware which will inhibit the high-level control bringing the system into compliance. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will implement the corrective software patch to inhibit high-level control according to the corrective action plan by June 22, 2015. For further questions please 203.262-8836
Quantity in commerce: 30 units distributed in the US
Distribution: US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.
Product codes and lots: P/N 709020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1079-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1079-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-06

Product code KXJ

K050190Class IIApolloVilla Sistemi Medicali S.P.A. / cleared 2005-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)