Juno DFR X-ray system
FDA Recall #Z-1079-2015 — Class II — December 14, 2014
Product Description
Juno DFR X-ray system
Reason for Recall
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
Recalling Firm
Villa Radiology Systems LLC — Oxford, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
30 units distributed in the US
Distribution
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.
Code Information
P/N 709020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated