The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1427-2017·Announced 2017-03-15

Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Footrest Detachment

Villa Sistemi Medicali is recalling 65 Juno DRF x-ray systems because the footrest can detach from the table, causing patients to fall.

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 3/5 (High).

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 involves a risk-of-harm product (fall from table) where injury has not been explicitly reported as a widespread outcome, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Villa Sistemi Medicali S.P.A. is recalling 65 units of the Juno DRF (Model 709020) general, multi-function x-ray systems. These devices are capable of routine radiographs and general fluoroscopy procedures. The recall is due to a safety hazard where the footrest of the device can detach from the table top while the patient is positioned on the table and the table is moving from a vertical position.

The incident that prompted this recall involved a patient falling from the table because the footrest detached during movement. The affected devices were distributed nationwide in the United States, including in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I. Specific serial numbers for the affected units are listed in the official recall documentation.

Healthcare facilities and consumers should stop using these devices immediately and contact the manufacturer for instructions on repair or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Manufacturer
Villa Sistemi Medicali S.P.A.
Category
Medical Device — X-Ray Systems
Hazard
Affected units
65

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Villa Sistemi Medicali S.P.A. 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 →

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