Z-1079-2015 Class II Terminated

Recalled by Villa Radiology Systems LLC — Oxford, CT

Recall Details

Product Type
Devices
Report Date
March 18, 2015
Initiation Date
December 14, 2014
Termination Date
March 16, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 units distributed in the US

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

Distribution Pattern

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