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.
Enforcement
- Recall Number
- Z-2056-2019
- Event ID
- 83400
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Agfa N.V.
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- August 7, 2019
- Initiation Date
- June 27, 2019
- Classification Date
- July 30, 2019
- Termination Date
- June 3, 2020
- Address
- Septestraat 27, N/A, Mortsel, N/A, N/A, Belgium
Description
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.
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Model/Serial Number/s: 00925, 00945, and 00949, 1136
US Nationwide Distribution
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