Device Recall DXD Imaging Package

Model Numbers DX-D 20G and DX-D 20C; Catalog Numbers ABC Code 5PYTM and 5PYUO

Radiology Devices

2

No

Nationwide Distribution (USA) including the states of: FL, IL, IN, KS, MI, MN, MS, NE,NY, OH, SC and WV.

Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) || Product Usage: || DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.