Agfa N.V. Septestraat 27 Mortsel Belgium 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 projec Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 projec
Brand
Agfa N.V. Septestraat 27 Mortsel Belgium
Lot Codes / Batch Numbers
Model/Serial Number/s: 00925, 00945, and 00949, 1136
Products Sold
Model/Serial Number/s: 00925, 00945, and 00949, 1136
Agfa N.V. Septestraat 27 Mortsel Belgium is recalling AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 8 due to The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026