Villa Radiology Juno DFR X-ray System Recalled for Control Defects
Villa Radiology Systems LLC is recalling 30 Juno DFR X-ray systems because they lack required audible signals, permanent activation, and manual override features.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the missing safety controls (audible signal, manual override) present a risk of harm to patients or operators, though no specific injuries are reported in the source text.
Plain-English summary
Villa Radiology Systems LLC is recalling 30 units of the Juno DFR X-ray system (P/N 709020) in the United States. The recall was initiated because the systems do not provide the appropriate audible signal, permanent activation, and manual override, despite operating in high-level control functionality.
The affected units were distributed to the states of Arizona, Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Michigan, Maryland, Mississippi, Massachusetts, Missouri, New York, Ohio, Pennsylvania, Utah, Tennessee, and Texas.
Consumers and healthcare facilities should contact Villa Radiology Systems LLC for information on corrective actions or repairs for the recalled equipment.
The recalled product
- Product
- Juno DFR X-ray system
- Manufacturer
- Villa Radiology Systems LLC
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- P/N 709020
Distribution
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