Agfa N.V. recalls AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated…

Recall date

June 27, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2056-2019

FDA classification

Class II

Brand / firm

Agfa N.V.

Sold / distributed

US Nationwide Distribution

Why it was recalled

The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.