Villa Radiology Systems LLC: Medical Device Recall in 2013 - (Recall #: Z-2160-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 2, 2013

Date Posted: September 25, 2013

Recall Number: Z-2160-2013

Event ID: 66024

Reason for Recall:

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

Status: Terminated

Product Quantity: 22 units within US

Code Information:

PN 709020

Distribution Pattern:

US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.

Voluntary or Mandated:

Voluntary: Firm initiated