Villa Radiology Juno DRF X-ray Systems Recalled for Injury Risk
Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that an 'injured person' was involved in the incident, which meets the rubric criteria for 'significant injury reports' under a Severe (4) classification.
Plain-English summary
Villa Radiology Systems LLC is recalling 66 units of the Juno DRF (Model 709020) multi-function x-ray systems. These devices are capable of routine radiograph and general fluoroscopy procedures. The recall was initiated after an analysis determined that an incident was caused by a chain of four faults.
The analysis identified that the injured person overcame a physical barrier to access a prohibited area not intended as a working position. Additionally, the device labeling and instructions for use did not explicitly exclude this prohibited area. The movement was activated inadvertently and continuously without being released, and the emergency stop was activated with a delay.
The affected units were distributed in the United States, including in Alabama, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, and Wisconsin. Consumers should contact the recalling firm for further instructions.
The recalled product
- Product
- Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
- Manufacturer
- Villa Radiology Systems LLC
- Affected units
- 66
Distribution
Part of a larger recall action
This product is one of 4 recalled by Villa Radiology Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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