AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Produ ...



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.
Components:
Units Affected:    4
Recall Date:    Jun 27, 2019
Mfg:
Agfa N.V.
Mfg Country:
Belgium
Recall ID:    83400
Product ID:    175071
Enforcement Date:    Aug 7, 2019
Termination Date:    Jun 3, 2020
Last Published:    Jun 3, 2020

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Emert Number:    Z-2056-2019
Emert Status:    Terminated