FDA-Device2014-08-20Class III

Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

AGFA Healthcare Corp.
Hazard

Unit was mislabeled with a factory label showing 32 KW output power.

Sold states
US in the state of WV
Affected count
1
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2176-2014

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