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 r
Hazard
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
What You Should Do
Remedy
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.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
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)
- Brand
- Agfa N.V. Septestraat 27 Mortsel Belgium
- UPC
- Model/Serial Number/s: 00925, 00945, and 00949, 1136
Units Affected
4