Villa Radiology Systems LLC recalls Juno DFR X-ray system

Recall date

December 14, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1079-2015

FDA classification

Class II

Brand / firm

Villa Radiology Systems LLC

Sold / distributed

US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.

Why it was recalled

The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Juno DFR X-ray system