Severity
Moderate
FDA Devices recall · Reported March 18, 2015
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
Villa Radiology Systems LLC recalled Juno DFR X-ray system - a moderate-severity action.
Juno DFR X-ray system was recalled by Villa Radiology Systems LLC in March 18, 2015. Reason: The system does not provide the appropriate audible signal, permanent activation, and manual override, althou…. Check the official notice for the remedy. Verify recall #Z-1079-2015 with the FDA Devices before acting.
The recall
Villa Radiology Systems LLC issued this moderate-severity FDA Devices recall-The system does not provide the appropriate audible signal, permanent activation, and manual override, althou….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1079-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1079-2015) was formally reported on March 18, 2015, with the manufacturer initiating the action on December 14, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Villa Radiology Systems LLC is listed as the recalling firm, operating out of Oxford, CT. Federal records list the affected scope as 30 units distributed in the US.
The documented reason for this recall is: The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
30 units distributed in the US
Related Recalls
6
6 from same agency
Juno DFR X-ray system
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1079-2015 |
| Date reported | March 18, 2015 |
| Date initiated | December 14, 2014 |
| Recalling firm | Villa Radiology Systems LLC |
| Firm location | Oxford, CT |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Same archive severity grade (Moderate), closest by report date among other firms and states.
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 18, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.