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AGFA Healthcare Corp. recalls AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to ai
Recalled April 5, 2017 · FDA recall Z-1698-2017 · AGFA Healthcare
Hazard
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored. · FDA Class II
Units
308
Sold at
Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada.
Description
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.
Product
AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
Manufacturer(s)
AGFA Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →