Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Juno DRF System. Mobile X-ray system These are general Recalled by Villa Radiology Systems LLC Due to It has been discovered that the Air Kerma...

Date: August 2, 2013
Company: Villa Radiology Systems LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Villa Radiology Systems LLC directly.

Affected Products

Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

Quantity: 22 units within US

Why Was This Recalled?

It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6

Where Was This Sold?

This product was distributed to 16 states: AL, AZ, CA, CT, IL, IN, IA, MD, MA, MI, MS, MO, NY, OH, PA, UT

Affected (16 states)Not affected

About Villa Radiology Systems LLC

Villa Radiology Systems LLC has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report