Home / Recalls / Medical Devices
AGFA Corp. recalls AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality i
Recalled July 30, 2014 · FDA recall Z-2081-2014 · AGFA
Hazard
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings. · FDA Class II
Units
216 units
Sold at
USA (nationwide) including the states of AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, WY and Internationally to Canada.
Description
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
Product
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.
Manufacturer(s)
AGFA Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →