The Recall Desk
SevereFDA (Devices)·Z-1063-2017·Announced 2017-02-01

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
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.

See all 4 products in this recall →