Recall Z-2056-2019
Agfa N.V. · initiated June 27, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model/Serial Number/s: 00925, 00945, and 00949, 1136
Reason for recall
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
FDA-determined cause: Device Design
Action taken
The firm sent notification letter dated June 27, 2019 to affected customers. The letter identified the affected product problem and actions to be taken. For questions about this matter,contact your local Agfa Imaging organization 1-877-777-2432 and please reference Problem Record. PRB2000198.
Details
- Recall number
- Z-2056-2019
- Initiated
- June 27, 2019
- Terminated
- June 3, 2020
- Product code
- JAA – System, X-Ray, Fluoroscopic, Image-Intensified
- Quantity
- 4
- Distribution
- US Nationwide Distribution
- Recalling firm
- Agfa N.V., Mortsel